High Tibial Osteotomy for Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Opening-wedge HTO; Procedure: Closing-wedge HTO

• Registration Number: NCT01977261
• Lead Sponsor: Erasmus Medical Center

Brief Summary

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

Detailed Description

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2013-10
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Study First Posted: 2013-11-06
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Radiological OA, medial joint pain and varus malalignment

Exclusion Criteria

• Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM <100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture > 10 degrees.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opening-wedge HTO	Opening-wedge HTO	Opening-wedge high tibial osteotomy fixated with a Puddu-plate
Closing-wedge HTO	Closing-wedge HTO	Closing-wedge high tibial osteotomy fixated with 2 staples

Primary Outcome Measures

Name	Time	Method
The achievement of an overcorrection of valgus of 4°.	one year	The achieved correction will be determined on a whole leg radiograph.

Secondary Outcome Measures

Name	Time	Method
Knee function	one year	Knee function will be measured with the Hospital for Special Surgery score
Walking distance	one year
Severity of pain	one year	Severity of pain will be measured with the visual analogue scale

Trial Locations

Locations (1)

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands