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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| McMaster University | OTHER |
| University of Southern California | OTHER |
| University of California, Irvine |
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The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.
Nearly half of all elderly hip fractures are femoral neck fractures (FNFs) and approximately 20% are minimally displaced. Internal fixation has remained the treatment of choice for these injuries because these fractures can be fixed in situ and the surgical implants can be inserted with little surgical dissection. Patients treated with internal fixation experience high complication rates, with the pooled risk of reoperation and mortality each above 14%. Preliminary data have suggested arthroplasty for minimally displaced fractures may lead to better patient outcomes, including improved ambulation, fewer reoperations, and a lower risk of death compared to internal fixation. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, the necessary evidence to make this significant practice change remains lacking.
The eventual definitive trial has significant potential to change clinical practice and optimize patient outcomes for individuals that experience a minimally displaced FNF. Treating minimally displaced FNFs with arthroplasty, instead of internal fixation, would be a paradigm shift in clinical care. This pilot study will demonstrate feasibility of the definitive trial and be used to refine aspects of the study protocol as necessary. If feasibility is successfully demonstrated, the pilot activities will be considered a vanguard phase for the definitive clinical trial.
Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture treated with surgery will be eligible to participate in the study. Patients will be randomized to receive either hip arthroplasty or internal fixation. Patients will be followed for 1 year, with visits occurring at 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, days at home, and health status will be collected.
The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroplasty | Experimental | A modern porous-coated press-fit or cemented hip arthroplasty prosthesis will be used at the treating surgeon's discretion. Press-fit implants that have no ingrowth or ongrowth surface will not be permitted. We recommend surgeons consider a total hip arthroplasty for younger active, independent participants; conversely, a hemiarthroplasty is recommended for more frail, lower-demand participants. Similarly, cemented arthroplasty for older adult participants is also recommended. The surgical approach and the use of post-operative hip precautions will be determined by the treating surgeon. |
|
| Internal Fixation | Active Comparator | Based on the fracture displacement eligibility criteria, minimal or no reduction is expected during the surgical procedure. However, the treating surgeon will be allowed to perform fracture reduction maneuvers if desired. Fixed angle devices and multiple screws will be permitted. The internal fixation device(s) will be inserted through a small lateral incision. If using multiple cancellous screws, an inverted triangle or similar screw pattern is recommended. Fixed angle devices, such as a sliding hip screw (with or without an anti-rotation screw) or newer multi-screw fixed angle devices will also be permitted. Internal fixation constructs combining cancellous screws and fixed angle devices will be permitted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroplasty | Procedure | The type of hip prothesis (hemi or total; cemented or uncemented) will be at the discretion of the treating surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Participant Enrollment | Participant enrollment will be assessed by monitoring screening and enrollment metrics, including:
| 12 months |
| Feasibility of Treatment Allocation | Feasibility of the treatment allocation will be assessed using the following metrics:
| 12 months |
| Refine Data Collection Methods | To refine the data collection methods, the following metrics will be reviewed:
| 12 months |
| Assess Protocol Compliance | The following metrics will be used to assess compliance with the protocol:
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Slobogean, MD | University of Maryland, Baltimore | Principal Investigator |
| Sheila Sprague, PhD | McMaster University | Principal Investigator |
| Joseph Patterson, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90007 | United States | ||
| Yale University |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D005592 | Fracture Fixation |
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| OTHER |
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| Internal Fixation | Procedure | Both fixed angle devices and multiple screws will be permitted for the internal fixation group. |
|
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| University of Maryland, R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| University of Maryland Capital Region Health | Largo | Maryland | 20774 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z2 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8V 1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D013812 | Therapeutics |