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

May 22, 2010 updated by: Tehran University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Using Iliac crest allograft in high tibial osteotomy
Procedure: Iliac crest allograft
Opening wedge osteotomy of proximal tibia with allograft from iliac crest
Active Comparator: B
Using iliac crest autograft in high tibial osteotomy
Procedure: Iliac crest autograft
open wedge osteotomy of proximal tibia using autogenous iliac bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range of motion of the knee
Time Frame: before op and at follow ups
before op and at follow ups
knee score (womac)
Time Frame: before op and at final follow up
before op and at final follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Seyyed Mohammad J Mortazavi, M.D., Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 5, 2008

First Submitted That Met QC Criteria

January 5, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 22, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 86-09-30-4111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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