An interventional study of TFNA and PFNA-II in Femur Fractures, sponsored by Synthes GmbH. Completed at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by Synthes GmbH (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally. The study will compare the safety and the effectiveness of two intramedullary nails (the investigational group is TFNA and the control group is PFNA-II).Patients enrolled at each site will be randomized in a ratio of 1:1, i.e. one patient assigned to surgery implanted with TFNA for each patient assigned to PFNA-II. Separate block randomization schedules within each site will be used to ensure equal distribution of treatment and control patients. Up to 15 centers will be approved to participate in this study.
Patient will be clinically followed after surgery at 1, 6, 12 and 24 weeks. The data up to and including 24 week follow up visit will be used in determining the primary safety and effectiveness of the TFNA.
The primary objective of this study is to evaluate whether fracture union rate, evaluated 24 weeks after proximal femur fracture, for the investigational TFNA intramedullary nail is non-inferior to that for currently available control product PFNA-II in patients with proximal femur fractures.
186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.
This study's enrollment of 188 is above the median of 61 across 114 interventional studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted after Synthes GmbH became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
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.
According to AO fracture classification, subjects with following fracture type:
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
using Trochanteric Fixation Nail Advanced to treat the fracture
Device: TFNA
Using Proximal Femoral Nail Antirotation to treat the fracture
Device: PFNA-II
intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
intramedullary nail ' Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Successful Fracture Union Rate 24 Weeks After Surgery
The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product
Time frame: 24 weeks
One hundred eighty-eight subjects were included in this study and randomly assigned to a study group; enrollment included 94 in the study group and 94 in the control group. Subjects were clinically followed after surgery at 1, 6, 12 and 24 weeks at the hospital.
| Milestone | TFNA Group (Study Group) | PFNA-II Group (Control Group) |
|---|---|---|
| Started | 94 | 94 |
| Fas | 93 | 92 |
| Pps | 81 | 83 |
| Completed | 82 | 86 |
| Not completed | 12 | 8 |
| Withdrew: Not implanted the device | 1 | 2 |
| Withdrew: Withdrawal by subject | 11 | 6 |
The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product
| Participants | TFNA Group (Study Group) | PFNA-II Group (Control Group) |
|---|---|---|
| Successful Fracture Union Rate 24 Weeks After Surgery | 81 | 83 |
Collected over Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TFNA Group (Study Group) | 2/93 (2.2%) | 18/93 (19.4%) | 93/93 (100%) |
| PFNA-II Group (Control Group) | 1/92 (1.1%) | 16/92 (17.4%) | 89/92 (96.7%) |
| Event | TFNA Group (Study Group) | PFNA-II Group (Control Group) |
|---|---|---|
| Non-device relatedProduct Issues | 18/93 | 16/92 |
| Device-relatedProduct Issues | 0/93 | 0/92 |
| Event | TFNA Group (Study Group) | PFNA-II Group (Control Group) |
|---|---|---|
| Non-device relatedProduct Issues | 93/93 | 89/92 |
| Device relatedProduct Issues | 0/93 | 0/92 |
3 subjects were not implanted with any device, so total 185 subjects were included in FAS.
| Age, Continuous(Years) | TFNA Group (Study Group) | PFNA-II Group (Control Group) | Total |
|---|---|---|---|
| Mean | 77.8 (30 to 91) | 74.1 (29 to 91) | 75.9 (29 to 91) |
| Sex: Female, Male(Participants) | TFNA Group (Study Group) | PFNA-II Group (Control Group) | Total |
|---|---|---|---|
| Female | 64 | 59 | 123 |
| Male | 29 | 33 | 62 |
| Race/Ethnicity, Customized(Participants) | TFNA Group (Study Group) | PFNA-II Group (Control Group) | Total |
|---|---|---|---|
| Han(Asian) | 89 | 91 | 180 |
| Others | 4 | 1 | 5 |
| Medical history(Participants) | TFNA Group (Study Group) | PFNA-II Group (Control Group) | Total |
|---|---|---|---|
| Osteoporosis — Yes | 56 | 55 | 111 |
| Osteoporosis — No | 37 | 37 | 74 |
| Malnutrition — Yes | 13 | 14 | 27 |
| Malnutrition — No | 80 | 78 | 158 |
| Anemia — Yes | 42 | 38 | 80 |
| Anemia — No | 51 | 54 | 105 |
| Hormone deficiency — Yes | 1 | 0 | 1 |
| Hormone deficiency — No | 92 | 92 | 184 |
| Diabetes — Yes | 28 | 18 | 46 |
| Diabetes — No | 65 | 74 | 139 |
| Smoke within one year — Yes | 5 | 5 | 10 |
| Smoke within one year — No | 88 | 87 | 175 |
| Drink within one year — Yes | 3 | 5 | 8 |
| Drink within one year — No | 90 | 87 | 177 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2018 to primary completion in May 2020, 17 months.
Results were first posted in May 2021, 1 year after primary completion.
Of 53 interventional studies with no phase under Femoral Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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