Trial Outcomes & Findings for DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial (NCT NCT00546429)
NCT ID: NCT00546429
Last Updated: 2023-06-06
Results Overview
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
COMPLETED
62 participants
4 weeks, 3, 6 and 12 months
2023-06-06
Participant Flow
Between September 2006 \& September 2009, 62 subjects were recruited and enrolled at 6 US clinics by orthopaedic surgeons. Each study site could enroll up to 20 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.
This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the ATN Trochanteric Nail. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.
Participant milestones
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
|
|---|---|
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Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
32
|
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Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
Baseline characteristics by cohort
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=62 Participants
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
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|---|---|
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Age, Continuous
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79.2 years
STANDARD_DEVIATION 14.1 • n=5 Participants
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|
Sex: Female, Male
Female
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42 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
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|
Region of Enrollment
United States · United States
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62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsMerle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Outcome measures
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=60 Participants
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
|
|---|---|
|
Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
4 Week Merle D'Aubigne for Pain Score (0 worst to 6 best)
|
4.1 Units on a scale
Standard Deviation 1.2
|
|
Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
3 Month Merle D'Aubigne Pain Score (0 worst to 6 best)
|
4.4 Units on a scale
Standard Deviation 1.4
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Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
6 Month Merle D'Aubigne Pain Score (0 worst to 6 best)
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4.5 Units on a scale
Standard Deviation 1.3
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Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
12 Month Merle D'Aubigne Pain Score (0 worst to 6 best)
|
4.6 Units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsMerle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Outcome measures
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=60 Participants
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
|
|---|---|
|
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
4 Week Merle D'Aubigne for Walk Score (0 worst to 6 best)
|
1.3 Units on a scale
Standard Deviation 1.3
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|
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
3 Month Merle D'Aubigne Walk Score (0 worst to 6 best)
|
2.6 Units on a scale
Standard Deviation 1.7
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|
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
6 Month Merle D'Aubigne Walk Score (0 worst to 6 best)
|
3.0 Units on a scale
Standard Deviation 1.9
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|
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
12 Month Merle D'Aubigne Walk Score (0 worst to 6 best)
|
2.7 Units on a scale
Standard Deviation 1.9
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PRIMARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsMerle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Outcome measures
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=60 Participants
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
|
|---|---|
|
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
4 Week Merle D'Aubigne for Mobility Score (0 worst to 6 best)
|
5.2 Units on a scale
Standard Deviation 1.3
|
|
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
3 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)
|
5.4 Units on a scale
Standard Deviation 1.0
|
|
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
6 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)
|
5.4 Units on a scale
Standard Deviation 1.0
|
|
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
12 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)
|
5.6 Units on a scale
Standard Deviation 0.8
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SECONDARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks, 3, 6 and 12 monthsOutcome measures
Outcome data not reported
Adverse Events
DePuy Orthopaedics ATN Trochanteric Nail System
Serious adverse events
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=62 participants at risk
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
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|---|---|
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Musculoskeletal and connective tissue disorders
Bone fracture acetabulum
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1.6%
1/62 • Number of events 1
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
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1.6%
1/62 • Number of events 1
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General disorders
Death
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1.6%
1/62 • Number of events 1
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Injury, poisoning and procedural complications
Implant removal
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1.6%
1/62 • Number of events 1
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Other adverse events
| Measure |
DePuy Orthopaedics ATN Trochanteric Nail System
n=62 participants at risk
The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Respiratory system
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6.5%
4/62 • Number of events 4
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60