Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft

Phase 3

Completed

• Conditions: Genovarum
• Interventions: Procedure: Iliac crest allograft; Procedure: Iliac crest autograft

• Registration Number: NCT00595712
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-05
• Study First Submitted QC: 2008-01-05
• Study First Posted: 2008-01-16
• Primary Completion: 2008-02
• Study Completion: 2010-02
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-22
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees
• at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning

Exclusion Criteria

• symptomatic lateral compartment osteoarthritis of knee
• rheumatoid arthritis or other inflammatory joint diseases
• less than 100 degrees of knee range of motion
• grade III laxity in knee collateral ligaments
• history of surgery or fracture in the limb
• >15 degrees flexion contracture
• age <16 or >60 years
• >20 degrees varus deformity
• failure to attend follow-up visits
• sever bone loss in medial tibial plateau or medial femoral condyle
• >1cm joint subluxation
• presence of lateral trust during walking
• presence of patella baja
• skin derangements on medial proximal tibia
• any form of nicotine addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Iliac crest allograft	Using Iliac crest allograft in high tibial osteotomy
B	Iliac crest autograft	Using iliac crest autograft in high tibial osteotomy

Primary Outcome Measures

Name	Time	Method
knee score (womac)	before op and at final follow up
Range of motion of the knee	before op and at follow ups

Trial Locations

Locations (1)

Imam Khomeini Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of