Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stryker Osteosynthesis | UNKNOWN |
| Global Research Solutions | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on rate of revision surgery in individuals with inter-trochanteric fractures. Secondary outcomes include fracture healing rates, fracture related complications, and health-related quality of life.
Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision of surgery rate and complication rate. The newest generation of Gamma3 nails have strong rationale suggesting significantly decreased rates of femoral shaft fractures and improved function. The improvements in implant design of the Gamma3 nail provide compelling rationale for the conduct of a large, definitive trial, and therefore a pilot study is being conducted to confirm or refute our ability to recruit patients and assess the consistency between site estimates and actual recruitment, determine the degree to which site investigators can adhere to trial protocol, confirm or refute our anticipated ability to achieve close to 100% follow- up, assess our ability to maintain 100% data quality, field test our case report forms for clarity and appropriateness, and to determine whether we can successfully manage the logistics of coordinating trial activities across multiple sites.
This trial is a pilot, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, 1 week, 3 months, 6 months, and 12 months after surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gamma3 intramedullary nail |
|
| 2 | Active Comparator | Sliding hip screw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma3 intramedullary nail (Stryker) | Procedure | The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of revision surgery | Revision surgery is classified as any unplanned surgery done to promote fracture healing, relieve pain, treat infection, or improve function include the following: 1) implant removal prior to fracture healing (to achieve union); 2) revision surgery with another internal fixation implant; 3) revision surgery to arthroplasty; 4) incision and drainage for deep infection at the bone implant interface; 5) correction of malunion; and 6) repair of a femoral shaft fracture. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | HRQL will be measured using using self-administered and interview-administered questionnaires. Functional outcome questionnaires will include a generic health status measurement instrument (SF-12v2), a hip function and pain questionnaire (WOMAC), a generic utility measure (EQ-5D), the Merle d'Aubigne (MDA) pain and function score, and the Parker mobility score. | Up to12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD FRCSC MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada | ||
| St. Joseph's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8832319 | Background | Parker MJ, Pryor GA. Gamma versus DHS nailing for extracapsular femoral fractures. Meta-analysis of ten randomised trials. Int Orthop. 1996;20(3):163-8. doi: 10.1007/s002640050055. | |
| 12151898 | Background | Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Sliding Hip Screw | Procedure | The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation. |
|
|
| Fracture healing rates | A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs. | Up to12 months |
| Complications | Complications include mortality, femoral shaft fracture, avascular necrosis, nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep). | Up to12 months |
| Hamilton |
| Ontario |
| L8N4A6 |
| Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C1R6 | Canada |
| Aarhus University Hospital | Aarhus | Denmark |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| 11879828 | Background | Harrington P, Nihal A, Singhania AK, Howell FR. Intramedullary hip screw versus sliding hip screw for unstable intertrochanteric femoral fractures in the elderly. Injury. 2002 Jan;33(1):23-8. doi: 10.1016/s0020-1383(01)00106-1. |
| D007869 |
| Leg Injuries |
| D013514 |
| Surgical Procedures, Operative |