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Clinical Trials/NCT01977261
NCT01977261
Completed
Not Applicable

High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial

Erasmus Medical Center1 site in 1 country92 target enrollmentJanuary 2001
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Erasmus Medical Center
Enrollment
92
Locations
1
Primary Endpoint
The achievement of an overcorrection of valgus of 4°.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2001
End Date
April 2004
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

T. Duivenvoorden

M.D.

Erasmus Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The achievement of an overcorrection of valgus of 4°.

Time Frame: one year

The achieved correction will be determined on a whole leg radiograph.

Secondary Outcomes

  • Knee function(one year)
  • Walking distance(one year)
  • Severity of pain(one year)

Study Sites (1)

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