A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique

May 12, 2010 updated by: Shahid Beheshti University of Medical Sciences
The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are various methods for correcting varus deformity; therefore the best surgical method must be individualized. We concluded that in a varus knee where only correction in the coronal plane without patella infra, changes in Q- angle, tibial plateau inclination is all that is needed, a retro- tubercle medial opening- wedge osteotomy is the preferred approach.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury

Exclusion Criteria:

  • fractures through compartments of the knee or the patella
  • osteoarthritis other than in the medial compartment
  • 10 degrees or more extension lag
  • tibial malrotation

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medial Opening-Wedge Osteotomy
Medial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee
Procedure: Retro-Tubercle Opening-Wedge High Tibial Osteotomy
Retro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patellar length (in mm)to the patellar tendon length (in mm)
Time Frame: up to 13 months
The length of the patella (in its longest diameter on a lateral x-ray) to the length of the patellar tendon is referred as Insall-Salvati index
up to 13 months
The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
Time Frame: up to 13 months
The length of the articular surface of the patella to the distance from the patella to the tibial plateau is referred as Blackburne-Peel index.
up to 13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps angle in degree
Time Frame: up to 13 months
The angle between the quadriceps vector and the line of pull of the patellar tendon from the centre of the patella to the tibial tubercle.
up to 13 months
Inclination of proximal tibial plateau in degree
Time Frame: up to 13 months
The angle between articular surface and lateral longitudinal axis of tibia.
up to 13 months

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Reza Abbasian, Dr., Shahid Beheshti University of Medical Sciences

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

January 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2010

Last Update Submitted That Met QC Criteria

May 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU-400/435

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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