An observational study in Tibial Fractures, sponsored by Synthes GmbH. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-11.
Sponsored by Synthes GmbH (part of Johnson & Johnson) · Observational
Case series of tibial plateau fractures using Norian Drillable.
This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.
32 studies on the registry are indexed under Tibial Plateau Fractures; 12 are open to participants now.
Browse Tibial Plateau Fractures studies →Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted before Synthes GmbH became part of Johnson & Johnson.
Compared within Tibial Plateau Fractures, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tibial Fractures. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Primary care clinic
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Norian Drillable Bone Void Filler
Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
Also known as: Norian Drillable
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)
Time frame: Day 0 (Day of surgery)
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)
Time frame: Day 0 (Day of surgery)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Time frame: At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Surgeons Overall Satisfaction With Norian Drillable
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Time frame: Surgery
Pain and Function Assessed With the Lysholm Knee Scale
The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.
Time frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Radiographic Parameters: Depression at Baseline
The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Baseline
Radiographic Parameters: Depression at Surgery
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Surgery
Radiographic Parameters: Depression at 6 Weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 6 week
Radiographic Parameters: Depression at 12 Weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 12 weeks
Radiographic Parameters: Depression at 26 Weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 26 weeks
Radiographic Parameters:: Depression at 52 Weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 52 weeks
Radiographic Parameters: Depression at 78 Weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 78 weeks
Radiographic Parameters: Condylar Widening at Baseline
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Baseline
Radiographic Parameters: Condylar Widening at Surgery
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Surgery
Radiographic Parameters: Condylar Widening at 6 Weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 6 weeks
Radiographic Parameters: Condylar Widening at 12 Weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 12 weeks
Radiographic Parameters: Condylar Widening at 26 Weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 26 weeks
Radiographic Parameters: Condylar Widening at 52 Weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 52 weeks
Radiographic Parameters: Condylar Widening at 78 Weeks
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 78 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Baseline
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: Surgery
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 6 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 12 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 26 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 52 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Time frame: 78 weeks
Knee Function and Stability: Extension at Baseline
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Extension at 6 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Extension at 12 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Extension at 26 Week
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Extension at 52 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Extension at 78 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks
Knee Function and Stability: Total Range of Motion at Baseline
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Total Range of Motion at 6 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Total Range of Motion at 12 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Total Range of Motion at 26 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Total Range of Motion at 52 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Total Range of Motion at 78 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks
Knee Function and Stability: Extension Stability at Baseline
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Extension Stability at 6 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Extension Stability at 12 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Extension Stability at 26 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Extension Stability at 52 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Extension Stability at 78 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks
| Milestone | Treatment |
|---|---|
| Started | 33 |
| Treated at baseline | 33 |
| 6 weeks | 33 |
| 12 weeks | 33 |
| 26 weeks | 33 |
| 52 weeks | 30 |
| 78 weeks | 28 |
| 104 weeks | 27 |
| Completed | 24 |
| Not completed | 9 |
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)
| Minutes | Treatment |
|---|---|
| Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment | 107.0 (52 to 392) |
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)
| Cubic Centimeters | Treatment |
|---|---|
| Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment | 114.0 ± 117.35 |
| participants | Treatment |
|---|---|
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device | 21 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
| Cases | Treatment |
|---|---|
| Easy | 27 |
| Moderate | 1 |
| Difficult | 0 |
| n/a | 5 |
The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.
| units on a scale | Treatment |
|---|---|
| Week 6, n=24 | 52.0 (0.0 to 86.7) |
| Week 12, n=23 | 66.7 (20.5 to 92.0) |
| Week 26, n=20 | 70.6 (17.5 to 86.1) |
| Week 52, n=24 | 75.0 (21.0 to 95.0) |
| Week 78, n=21 | 67.8 (20.5 to 92.0) |
| Week 104, n=4 | 73.5 (61.0 to 95.0) |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.
| Cases | Treatment |
|---|---|
| Easy | 5 |
| Moderate | 0 |
| Difficult | 0 |
| n/a | 28 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone.
| Cases | Treatment |
|---|---|
| Easy | 8 |
| Moderate | 0 |
| Difficult | 0 |
| n/a | 25 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
| Cases | Treatment |
|---|---|
| Easy | 29 |
| Moderate | 1 |
| Difficult | 0 |
| n/a | 3 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
| Cases | Treatment |
|---|---|
| Exceptional | 6 |
| Very easy | 16 |
| Somewhat easy | 3 |
| Average | 6 |
| Fair | 1 |
| Somewhat difficult | 0 |
| Very difficult | 0 |
| Missing | 1 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
| Cases | Treatment |
|---|---|
| Exceptional | 4 |
| Very easy | 15 |
| Somewhat easy | 6 |
| Average | 7 |
| Fair | 0 |
| Somewhat difficult | 0 |
| Very difficult | 0 |
| Missing | 1 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
| Cases | Treatment |
|---|---|
| Exceptional | 6 |
| Very easy | 9 |
| Somewhat easy | 10 |
| Average | 6 |
| Fair | 0 |
| Somewhat difficult | 1 |
| Very difficult | 0 |
| Missing | 1 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
| Cases | Treatment |
|---|---|
| Exceptional | 2 |
| Very easy | 15 |
| Somewhat easy | 6 |
| Average | 9 |
| Fair | 0 |
| Somewhat difficult | 0 |
| Very difficult | 0 |
| Missing | 1 |
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
| Cases | Treatment |
|---|---|
| Exceptional | 6 |
| Very easy | 11 |
| Somewhat easy | 10 |
| Average | 4 |
| Fair | 0 |
| Somewhat difficult | 1 |
| Very difficult | 0 |
| Missing | 1 |
The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 0 |
| Present | 27 |
| Missing | 1 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 15 |
| Present | 12 |
| Missing | 1 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 22 |
| Present | 4 |
| Missing | 2 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 16 |
| Present | 7 |
| Missing | 5 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 16 |
| Present | 5 |
| Missing | 7 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 12 |
| Present | 8 |
| Missing | 8 |
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 13 |
| Present | 8 |
| Missing | 7 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 6 |
| Present | 21 |
| Missing | 1 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 20 |
| Present | 7 |
| Missing | 1 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 24 |
| Present | 2 |
| Missing | 2 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 23 |
| Present | 0 |
| Missing | 5 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 20 |
| Present | 1 |
| Missing | 7 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 20 |
| Present | 0 |
| Missing | 8 |
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 20 |
| Present | 0 |
| Missing | 8 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 16 |
| Present | 9 |
| Missing | 3 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 23 |
| Present | 4 |
| Missing | 1 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 24 |
| Present | 2 |
| Missing | 2 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 21 |
| Present | 3 |
| Missing | 4 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 19 |
| Present | 2 |
| Missing | 7 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 17 |
| Present | 3 |
| Missing | 8 |
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
| participants | Treatment |
|---|---|
| Not present | 17 |
| Present | 3 |
| Missing | 8 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 16 |
| 0-10 Degrees | 10 |
| Missing | 2 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 20 |
| 0-10 Degrees | 6 |
| Missing | 2 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 21 |
| 0-10 degrees | 2 |
| Missing | 5 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 18 |
| 0-10 degrees | 3 |
| Missing | 7 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 20 |
| 0-10 degrees | 4 |
| Missing | 4 |
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal | 19 |
| 0-10 Degrees | 2 |
| Missing | 7 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 3 |
| At least 120 degrees | 4 |
| At least 90 degrees | 8 |
| At least 60 degrees | 5 |
| At least 30 degrees | 1 |
| At least 0-30 degrees | 3 |
| Missing | 4 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 4 |
| At least 120 degrees | 6 |
| At least 90 degrees | 13 |
| At least 60 degrees | 2 |
| At least 30 degrees | 2 |
| At least 0-30 degrees | 0 |
| Missing | 1 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 10 |
| At least 120 degrees | 9 |
| At least 90 degrees | 2 |
| At least 60 degrees | 0 |
| At least 30 degrees | 2 |
| At least 0-30 degrees | 0 |
| Missing | 5 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 4 |
| At least 120 degrees | 11 |
| At least 90 degrees | 4 |
| At least 60 degrees | 1 |
| At least 30 degrees | 1 |
| At least 0-30 degrees | 0 |
| Missing | 7 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 16 |
| At least 120 degrees | 5 |
| At least 90 degrees | 1 |
| At least 60 degrees | 1 |
| At least 30 degrees | 1 |
| At least 0-30 degrees | 0 |
| Missing | 4 |
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
| Cases | Treatment |
|---|---|
| Very satisfied | 21 |
| Satisfied | 2 |
| Somewhat satisfied | 6 |
| Average | 1 |
| Not dissatisfied | 0 |
| Somewhat dissatisfied | 2 |
| Very dissatisfied | 0 |
| Missing | 1 |
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| At least 140 degrees | 10 |
| At least 120 degrees | 9 |
| At least 90 degrees | 0 |
| At least 60 degrees | 2 |
| At least 30 degrees | 0 |
| At least 0-30 degrees | 0 |
| Missing | 7 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 13 |
| Abnormal instability | 6 |
| Instability in extension <10 degrees | 3 |
| Instability in extension >10 degrees | 1 |
| Missing | 5 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 23 |
| Abnormal instability | 3 |
| Instability in extension <10 degrees | 1 |
| Instability in extension >10 degrees | 0 |
| Missing | 1 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 22 |
| Abnormal instability | 1 |
| Instability in extension <10 degrees | 0 |
| Instability in extension >10 degrees | 0 |
| Missing | 5 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 20 |
| Abnormal instability | 0 |
| Instability in extension <10 degrees | 1 |
| Instability in extension >10 degrees | 0 |
| Missing | 7 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 22 |
| Abnormal instability | 1 |
| Instability in extension <10 degrees | 1 |
| Instability in extension >10 degrees | 0 |
| Missing | 4 |
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
| participants | Treatment |
|---|---|
| Normal stability | 17 |
| Abnormal instability | 3 |
| Instability in extension <10 degrees | 1 |
| Instability in extension >10 degrees | 0 |
| Missing | 7 |
Collected over Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 15/33 (45.5%) | 15/33 (45.5%) |
| Event | Treatment |
|---|---|
| CARDIAC FAILURE CONGESTIVECardiac disorders | 2/33 |
| INFECTIONInfections and infestations | 2/33 |
| FALLInjury, poisoning and procedural complications | 2/33 |
| LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTIONInjury, poisoning and procedural complications | 2/33 |
| AORTIC VALVE STENOSISCardiac disorders | 1/33 |
| CARDIAC FAILURECardiac disorders | 1/33 |
| DIARRHOEAGastrointestinal disorders | 1/33 |
| DUODENAL ULCERGastrointestinal disorders | 1/33 |
| DEVICE EXTRUSIONGeneral disorders | 1/33 |
| INFLAMMATIONGeneral disorders | 1/33 |
| Event | Treatment |
|---|---|
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 2/33 |
| ABDOMINAL PAIN LOWERGastrointestinal disorders | 1/33 |
| NON-CARDIAC CHEST PAINGeneral disorders | 1/33 |
| MEDICAL DEVICE PAINGeneral disorders | 1/33 |
| PAINGeneral disorders | 1/33 |
| DEVICE EXTRUSIONGeneral disorders | 1/33 |
| FALLInjury, poisoning and procedural complications | 1/33 |
| LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTIONInjury, poisoning and procedural complications | 1/33 |
| MENISCUS INJURYInjury, poisoning and procedural complications | 1/33 |
| RIB FRACTUREInjury, poisoning and procedural complications | 1/33 |
All patients enrolled and treated with Norian Drillable Bone Void Filler.
| Age, Continuous(Years) | Treatment |
|---|---|
| Mean | 56.6 ± 15.37 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 20 |
| Male | 13 |
| Race/Ethnicity, Customized(participants) | Treatment |
|---|---|
| White | 28 |
| Asian | 1 |
| Black | 0 |
| Indian | 0 |
| Other | 4 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| Australia | 10 |
| Netherlands | 6 |
| Norway | 16 |
| China | 1 |
| Height (n=32)(centimeter) | Treatment |
|---|---|
| Mean | 169.5 ± 9.85 |
| Weight (n=32)(kilogram) | Treatment |
|---|---|
| Mean | 75.5 ± 18.33 |
| BMI (n=32)(kg/m2) | Treatment |
|---|---|
| Mean | 26.3 ± 5.78 |
| Exercise per week(participants) | Treatment |
|---|---|
| Never | 4 |
| 1-2 times per week | 9 |
| 3-4 times per week | 9 |
| 5 or more times per week | 9 |
| Missing | 2 |
6 further baseline measures are reported on the registry.
The record gives a start of Sep 2008, a primary completion of Sep 2013 and a completion of Sep 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2015, 1 year 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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