Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Not Applicable

• Conditions: Femur Fracture

• Registration Number: NCT00686023
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.

Detailed Description

patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.

group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.

weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)

outcomes: death within first year

postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

Study Timeline

• Status Verified: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Last Update Submitted: 2008-05-28
• Study First Posted: 2008-05-29
• Last Update Posted: 2008-05-29
• Study Start: 2008-06
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Pertrochanteric femur fracture
• Unilateral
• Age over 60 years
• Low energy trauma
• ASA score 0-3

Exclusion Criteria

• Reverse oblique fractures
• Pathological fractures
• Severe osteoarthritis of the hip joint
• Previous operations on same leg
• ASA score 4-5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
death within 1 year of operation	4 years

Trial Locations

Locations (1)

TASMC; 🇮🇱 Tel Aviv, Israel