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The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
Proximal femoral fractures are among the most common femoral fractures. In the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. Intermedullary nailing is an alternative to plate and screw treatment. Weight bearing is allowed and the procedure can be a less invasive. Among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. Trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. This study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the ATN system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Monitoring of trochanteric fractures after treatment with the ATN system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramedullary nailing | Device | Trochanteric nailing for proximal femoral fractures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success in Terms of the Merle D'Aubigne Postel Score for Pain Category | 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 | 4 weeks, 3, 6 and 12 months |
| Success in Terms of the Merle D'Aubigne Postel Score for Walk Category | 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 | 4 weeks, 3, 6 and 12 months |
| Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category | 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 | 4 weeks, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Measure (LEM) | 4 weeks, 3, 6 and 12 months | |
| Medical Imaging | 4 weeks, 3, 6 and 12 months | |
| Six Item Screener and Ambulatory Status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Himden | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Front Range Orthopaedics | Colorado Springs | Colorado | 80910 | United States | ||
| Orthopaedic Physicians of Colorado |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success in Terms of the Merle D'Aubigne Postel Score for Pain Category | 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 | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks, 3, 6 and 12 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone fracture acetabulum | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory system | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Himden | DePuy Orthopaedics, Inc. | 574-372-7231 | SHimden@its.jnj.com |
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| ID | Term |
|---|---|
| D000092526 | Proximal Femoral Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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| 4 weeks, 3, 6 and 12 months |
| SF-12 | 4 weeks, 3, 6 and 12 months |
| Englewood |
| Colorado |
| 80110 |
| United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Blue Ridge Bone and Joint | Asheville | North Carolina | 28801 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Lower Extremity Measure (LEM) | Not Posted | 4 weeks, 3, 6 and 12 months | Participants |
| Secondary | Medical Imaging | Not Posted | 4 weeks, 3, 6 and 12 months | Participants |
| Secondary | Six Item Screener and Ambulatory Status | Not Posted | 4 weeks, 3, 6 and 12 months | Participants |
| Secondary | SF-12 | Not Posted | 4 weeks, 3, 6 and 12 months | Participants |
| Primary | Success in Terms of the Merle D'Aubigne Postel Score for Walk Category | 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 | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks, 3, 6 and 12 months |
|
|
|
| Primary | Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category | 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 | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks, 3, 6 and 12 months |
|
|
|
| 3 |
| 62 |
| 4 |
| 62 |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | This subject died and which is also noted as an adverse event in this study. |
|
| Death | General disorders | This subject suffered from cancer which is also noted as an adverse event in this study. |
|
| Implant removal | Injury, poisoning and procedural complications |
|
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| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D013514 |
| Surgical Procedures, Operative |
| D004358 | Drug Therapy |
|
| 12 Month Merle D'Aubigne Walk Score (0 worst to 6 best) |
|
|
| 12 Month Merle D'Aubigne Mobility Score (0 worst to 6 best) |
|