A Phase 4 interventional study of Kyphon® Curette in Vertebral Body Compression Fractures (VCFs), sponsored by Medtronic Spine LLC. Completed at 13 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Medtronic Spine LLC (part of Medtronic) · Phase 4, Interventional, and Treatment
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's enrollment of 120 is above the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Medtronic Spine LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted after Medtronic Spine LLC became part of Medtronic.
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.
One painful VCF meeting all of the following criteria:
Exclusion Criteria:
Pre-existing conditions contrary to balloon kyphoplasty, such as:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps.
Device: Kyphon® Curette
All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps.
Device: Kyphon® Curette
The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Time frame: Baseline and 48-hr post-procedure
Index Vertebral Body Height Restored in Millimeters.
Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.
Time frame: Baseline and 48 hours after procedure
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.
Time frame: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Time frame: baseline and intra-operative
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Time frame: Baseline and 48 hr post-procedure
Deformity Correction Assessed by Local Cobb Angle (LCA)
The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Time frame: baseline and 48 hr post-procedure
Change in Back Pain.
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Time frame: Baseline and 48 hr post-procedure
Change in Ambulatory Status
Ambulatory status was assessed by subjective patient questionnaire.
Time frame: Baseline and 48 hrs post-procedure
| Milestone | Curette-First | IBT-First | Non-treated Patients |
|---|---|---|---|
| Started | 57 | 55 | 8 |
| Completed | 53 | 54 | 0 |
| Not completed | 4 | 1 | 8 |
| Withdrew: Withdrawal by subject | 1 | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 2 |
| Withdrew: Death | 2 | 0 | 0 |
| Withdrew: Unrelated medical problem | 0 | 1 | 0 |
| Withdrew: Non-medical problem | 0 | 0 | 1 |
| Withdrew: No longer met enrollment criteria | 0 | 0 | 3 |
| percent change | Curette-First | IBT-First |
|---|---|---|
| Anterior vertebral measurement (n=52, 50) | 9.72 ± 12.85 | 11.77 ± 13.23 |
| Mid-vertebral measurement (n=52, 50) | 8.14 ± 9.96 | 9.07 ± 10.31 |
| Posterior vertebral measurement (n=52, 50) | 2.59 ± 5.15 | 4.21 ± 6.49 |
Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.
| mm | Curette-First | IBT-First |
|---|---|---|
| Anterior VBH at baseline (n=54, 53) | 14.15 ± 5.25 | 14.27 ± 5.02 |
| Anterior VBH at 48 hr post-procedure (n=56, 51) | 16.65 ± 4.75 | 17.32 ± 4.33 |
| Anterior change in VBH (n=53, 50) | 2.28 ± 2.89 | 2.78 ± 3.11 |
| Midpoint VBH at baseline (n=54, 53) | 13.98 ± 4.12 | 14.21 ± 4.07 |
| Midpoint VBH at 48 hr post-procedure (n=56, 51) | 16.22 ± 4.01 | 16.62 ± 3.39 |
| Midpoint change in VBH (n=53, 50) | 1.98 ± 2.38 | 2.25 ± 2.58 |
| Posterior VBH at baseline (n=54, 53) | 22.79 ± 3.61 | 22.94 ± 4.32 |
| Posterior VBH at 48 hr post-procedure (n=56, 51) | 23.57 ± 3.99 | 24.02 ± 3.59 |
| Posterior change in VBH (n=53, 50) | 0.65 ± 1.29 | 1.05 ± 1.65 |
Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.
| mm | IBT-First |
|---|---|
| Anterior VBH at intra-op with Bolster (n=47) | 17.03 ± 4.72 |
| Anterior VBH at Intra-op 1st IBT (n=49) | 18.40 ± 4.67 |
| Anterior VBH change (n=47) | 1.25 ± 1.94 |
| Middle VBH at intra-op with Bolster (n=47) | 15.99 ± 3.60 |
| Middle VBH at Intra-op 1st IBT (n=49) | 17.00 ± 3.32 |
| Middle VBH change (n=47) | 0.94 ± 1.38 |
| Posterior VBH at intra-op with Bolster (n=47) | 23.68 ± 3.85 |
| Posterior VBH at Intra-op 1st IBT (n=49) | 24.05 ± 3.61 |
| Posterior VBH change (n=47) | 0.37 ± 0.81 |
| mm | Curette-First | IBT-First |
|---|---|---|
| Anterior VBH at baseline (n=54, 53) | 14.15 ± 5.25 | 14.27 ± 5.02 |
| Anterior VBH at intra-op with Bolster (n=50, 47) | 16.93 ± 4.99 | 17.03 ± 4.72 |
| Anterior VBH gained (n=47, 46) | 2.96 ± 3.55 | 3.05 ± 3.21 |
| Middle VBH at baseline (n=54, 53) | 13.98 ± 4.12 | 14.21 ± 4.07 |
| Middle VBH at intra-op with Bolster (n=50, 47) | 15.96 ± 4.36 | 15.99 ± 3.60 |
| Middle VBH gained (n=47, 46) | 1.88 ± 2.64 | 2.14 ± 2.48 |
| Posterior VBH at baseline (n=54, 53) | 22.79 ± 3.61 | 22.94 ± 4.32 |
| Posterior VBH at Intra-op with Bolser (n=50, 47) | 23.41 ± 4.02 | 23.68 ± 3.85 |
| Posterior VBH gained (47, 46) | 0.64 ± 1.69 | 0.95 ± 1.53 |
The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
| degree | Curette-First | IBT-First |
|---|---|---|
| VBA at baseline (n=54, 53) | -15.5 ± 7.17 | -15.1 ± 7.82 |
| VBA at 48 hr post-procedure (n=56, 51) | -12.4 ± 6.23 | -11.5 ± 6.84 |
| Angle change (n=53, 50) | 2.88 ± 4.48 | 3.00 ± 4.42 |
The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
| degree | Curette-First | IBT-First |
|---|---|---|
| LCA at Baseline (n=53, 50) | -13.8 ± 15.09 | -11.5 ± 17.82 |
| LCA at 48 hr post-procedure (n=56, 49) | -10.70 ± 16.28 | -7.88 ± 16.29 |
| Angle change (n=52, 48) | 1.36 ± 3.68 | 1.87 ± 3.63 |
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
| units on a scale | Curette-First | IBT-First |
|---|---|---|
| Back pain at baseline (n=57, 55) | 7.7 ± 1.3 | 7.5 ± 1.3 |
| Back pain at 48 hr post-procedure (n=57, 55) | 3.0 ± 2.0 | 3.3 ± 1.9 |
| Back pain change from baseline (n=57, 55) | -4.7 ± 1.9 | -4.2 ± 1.9 |
Ambulatory status was assessed by subjective patient questionnaire.
| participants | Curette-First | IBT-First |
|---|---|---|
| Able to walk without assistance -- baseline | 36 | 34 |
| Able to walk with aid -- baseline | 18 | 21 |
| Must use wheelchair or bedridden -- baseline | 3 | 0 |
| Able to walk without assistance -- 48 hrs post-op | 48 | 42 |
| Able to walk with aid -- 48 hrs post-op | 9 | 12 |
| Must use wheelchair or bedridden -- 48 hrs post-op | 0 | 1 |
| No change | 43 | 40 |
| Improved | 13 | 11 |
| Worsened | 1 | 4 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Curette-First | — | 5/57 (8.8%) | 12/57 (21.1%) |
| IBT-First | — | 8/55 (14.5%) | 11/55 (20%) |
| Event | Curette-First | IBT-First |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 0/57 | 2/55 |
| Abdominal pain upperGastrointestinal disorders | 0/57 | 1/55 |
| DiverticulitisInfections and infestations | 0/57 | 1/55 |
| Lung infectionInfections and infestations | 0/57 | 1/55 |
| Urinary tract infectionInfections and infestations | 0/57 | 1/55 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 1/57 | 1/55 |
| Spinal meningioma benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/57 | 1/55 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 0/57 | 1/55 |
| Atrial fibrillationCardiac disorders | 1/57 | 0/55 |
| Post procedural pneumoniaInfections and infestations | 1/57 | 0/55 |
| Event | Curette-First | IBT-First |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 1/57 | 2/55 |
| Confusion postoperativeNervous system disorders | 2/57 | 0/55 |
| HeadacheNervous system disorders | 2/57 | 1/55 |
| VertigoEar and labyrinth disorders | 0/57 | 1/55 |
| ConstipationGastrointestinal disorders | 0/57 | 1/55 |
| DiarrhoeaGastrointestinal disorders | 0/57 | 1/55 |
| Helicobacter gastritisInfections and infestations | 0/57 | 1/55 |
| Urinary tract infectionInfections and infestations | 0/57 | 1/55 |
| Post procedural haematomaInjury, poisoning and procedural complications | 0/57 | 1/55 |
| Procedural painInjury, poisoning and procedural complications | 0/57 | 1/55 |
| Age, Continuous(years) | Curette-First | IBT-First | Total |
|---|---|---|---|
| Mean | 73.6 ± 8.4 | 76.0 ± 9.4 | 74.8 ± 8.9 |
| Sex: Female, Male(Participants) | Curette-First | IBT-First | Total |
|---|---|---|---|
| Female | 47 | 41 | 88 |
| Male | 10 | 14 | 24 |
| Race/Ethnicity, Customized(participants) | Curette-First | IBT-First | Total |
|---|---|---|---|
| Caucasian | 55 | 55 | 110 |
| Hispanic | 1 | 0 | 1 |
| Middle Eastern | 1 | 0 | 1 |
| Region of Enrollment(participants) | Curette-First | IBT-First | Total |
|---|---|---|---|
| United States | 13 | 18 | 31 |
| Belgium | 18 | 16 | 34 |
| Germany | 26 | 21 | 47 |
| Smoking history(Participants) | Curette-First | IBT-First | Total |
|---|---|---|---|
| Never Smoked | 36 | 36 | 72 |
| Current Smoker | 7 | 5 | 12 |
| Former Smoker | 14 | 14 | 28 |
The record gives a start of Feb 2009, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2011, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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