NCT01380444

Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 880 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Femoral Neck Fractures
• Intertrochanteric Fracture

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2011-06-27
• Last updated: 2019-03-07

Locations

26 sites across 12 countries: United States, Australia, Canada, China, Colombia, Denmark, Germany, Japan, Netherlands, Norway, South Africa, United Kingdom