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

Genu Varum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122017
• Other study ID #: SBMU-400/435
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: May 12, 2010
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: April 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genu Varum

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 13 months	No
Primary	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.	up to 13 months	No
Secondary	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.	up to 13 months	No
Secondary	Inclination of proximal tibial plateau in degree	The angle between articular surface and lateral longitudinal axis of tibia.	up to 13 months	No