Back to resultsA Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
Primary Purpose
Genu Varum
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Retro-Tubercle Opening-Wedge High Tibial Osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Genu Varum
Eligibility Criteria
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
Sites / Locations
- Shahid Beheshti University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medial Opening-Wedge Osteotomy
Arm Description
Medial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee
Outcomes
Primary Outcome Measures
The proportion of patellar length (in mm)to the patellar tendon length (in mm)
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
The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
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.
Secondary Outcome Measures
Quadriceps angle in degree
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.
Inclination of proximal tibial plateau in degree
The angle between articular surface and lateral longitudinal axis of tibia.
Full Information
NCT ID
NCT01122017
First Posted
December 1, 2009
Last Updated
May 12, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01122017
Brief Title
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
Official Title
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genu Varum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medial Opening-Wedge Osteotomy
Arm Type
Experimental
Arm Description
Medial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee
Intervention Type
Procedure
Intervention Name(s)
Retro-Tubercle Opening-Wedge High Tibial Osteotomy
Intervention Description
Retro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee.
Primary Outcome Measure Information:
Title
The proportion of patellar length (in mm)to the patellar tendon length (in mm)
Description
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
Time Frame
up to 13 months
Title
The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)
Description
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.
Time Frame
up to 13 months
Secondary Outcome Measure Information:
Title
Quadriceps angle in degree
Description
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.
Time Frame
up to 13 months
Title
Inclination of proximal tibial plateau in degree
Description
The angle between articular surface and lateral longitudinal axis of tibia.
Time Frame
up to 13 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Reza Abbasian, Dr.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique
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