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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Genovarum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

Using Iliac crest allograft in high tibial osteotomy

Group Type ACTIVE_COMPARATOR

Iliac crest allograft

Intervention Type PROCEDURE

Opening wedge osteotomy of proximal tibia with allograft from iliac crest

B

Using iliac crest autograft in high tibial osteotomy

Group Type ACTIVE_COMPARATOR

Iliac crest autograft

Intervention Type PROCEDURE

open wedge osteotomy of proximal tibia using autogenous iliac bone graft

Interventions

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Iliac crest allograft

Opening wedge osteotomy of proximal tibia with allograft from iliac crest

Intervention Type PROCEDURE

Iliac crest autograft

open wedge osteotomy of proximal tibia using autogenous iliac bone graft

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No