CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 880 enrolled
Drug / intervention
Gamma3 Intramedullary Nails (Stryker) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01380444
NCT01380444N/ACompleted
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A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

Stryker Trauma and Extremities·interventional·Posted Jun 27, 2011·Updated Mar 7, 2019

In Brief

A clinical study evaluating Gamma3 Intramedullary Nails (Stryker) and Sliding Hip Screws for Femoral Neck Fractures and Intertrochanteric Fracture. Completed, enrolled 880 participants across 26 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemoral Neck Fractures, Intertrochanteric Fracture
CountriesAustralia, Canada, China, Colombia, Denmark, Germany, Japan, Netherlands, Norway, South Africa, United Kingdom, United States
CollaboratorsGlobal Research Solutions

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.0 years ago

Interventions

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.

Sliding Hip Screwsprocedure

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.