Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation (INSITE)
|ClinicalTrials.gov Identifier: NCT01380444|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fractures Intertrochanteric Fracture||Procedure: Gamma3 Intramedullary Nails (Stryker) Procedure: Sliding Hip Screws||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||880 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip|
|Actual Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Active Comparator: 1
Gamma3 Intramedullary Nails
Procedure: Gamma3 Intramedullary Nails (Stryker)
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.
Active Comparator: 2
Sliding Hip Screws
Procedure: Sliding Hip Screws
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.
- Health Related Quality of Life [ Time Frame: Up to 104 weeks ]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.
- Health Related Quality of Life [ Time Frame: Up to 104 weeks ]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.
- Fracture healing rates [ Time Frame: Up to 104 weeks ]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.
- Fracture-related adverse events [ Time Frame: Up to 104 weeks ]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).
- Revision surgery rates [ Time Frame: Up to 104 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380444
Show 26 Study Locations
|Principal Investigator:||Mohit Bhandari, MD, PhD, FRCSC||Global Research Solutions|
|Study Director:||Georgia Mitchell||Stryker Trauma GmbH|