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| ID | Type | Description | Link |
|---|---|---|---|
| 96308751 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| Global Research Solutions | INDUSTRY |
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The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
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 surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.
This trial is a definitive, 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, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gamma3 Intramedullary Nails |
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| 2 | Active Comparator | Sliding Hip Screws |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma3 Intramedullary Nails (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 |
|---|---|---|
| Health Related Quality of Life | To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures. | Up to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured with the Parker mobility score and the Harris Hip Score. | Up to 104 weeks |
| Fracture healing rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD, PhD, FRCSC | Global Research Solutions | Principal Investigator |
| Georgia Mitchell | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Fresno | California | 93721 | United States | ||
| San Francisco General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 19550235 | Background | Bhandari M, Schemitsch E, Jonsson A, Zlowodzki M, Haidukewych GJ. Gamma nails revisited: gamma nails versus compression hip screws in the management of intertrochanteric fractures of the hip: a meta-analysis. J Orthop Trauma. 2009 Jul;23(6):460-4. doi: 10.1097/BOT.0b013e318162f67f. |
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| Sliding Hip Screws | 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. |
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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 to 104 weeks |
| Fracture-related adverse events | Including mortality, femoral shaft fracture, avascular necrosis (although rare in trochanteric fractures), nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep). | Up to 104 weeks |
| Revision surgery rates | Any unplanned surgery after the initial fixation to promote fracture healing (non-union), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event. | Up to 104 weeks |
| San Francisco |
| California |
| 94110 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Scott&White Memorial Hospital | Temple | Texas | 76508 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| The Royal Melbourne Hospital | Parkville | Victoria | 3039 | Australia |
| Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3A 1R9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| Chaoyang Hospital | Beijing | Beijing Municipality | 100020 | China |
| Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| 2nd Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| Clinica El Rosario Sede El Tesoro | Medellín | Antioquia | Colombia |
| Hospital Universitario Santa Clara | Bogotá | Cundinamarca | Colombia |
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | 23538 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| Tsukuba Medical Center | Tsukuba | Ibaraki | 305-8558 | Japan |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 | Netherlands |
| Helse Sunnmore Alesund Sjukehus | Ålesund | 6026 | Norway |
| Charlotte Maxeke Johannesburg Academic Hospital | Parktown | 2193 | South Africa |
| Frenchay Hospital | Bristol | BS16 1LE | United Kingdom |
| The Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| The Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| 18646058 | Background | Parker MJ, Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000093. doi: 10.1002/14651858.CD000093.pub4. |
| 37278998 | Derived | Schemitsch EH, Nowak LL, Schulz AP, Brink O, Poolman RW, Mehta S, Stengel D, Zhang CQ, Martinez S, Kinner B, Chesser TJS, Bhandari M; INSITE Investigators. Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317164. doi: 10.1001/jamanetworkopen.2023.17164. |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D005594 | Fracture Fixation, Intramedullary |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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