High Tibial Osteotomy for Osteoarthritis of the Knee (HTO)

October 30, 2013 updated by: T. Duivenvoorden, Erasmus Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

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

  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Centre

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Opening-wedge HTO
Opening-wedge high tibial osteotomy fixated with a Puddu-plate
Procedure: Opening-wedge HTO
Opening-wedge high tibial osteotomy fixated with a Puddu plate
Other Names:
  • open wedge high tibial osteotomy
Active Comparator: Closing-wedge HTO
Closing-wedge high tibial osteotomy fixated with 2 staples
Procedure: Closing-wedge HTO
Closing-wedge high tibial osteotomy fixated with two staples
Other Names:
  • Closed wedge high tibial osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The achievement of an overcorrection of valgus of 4°.
Time Frame: one year
The achieved correction will be determined on a whole leg radiograph.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pain
Time Frame: one year
Severity of pain will be measured with the visual analogue scale
one year
Knee function
Time Frame: one year
Knee function will be measured with the Hospital for Special Surgery score
one year
Walking distance
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: one year
Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury.
one year

Collaborators and Investigators

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

Sponsor

Erasmus Medical Center

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, 2001

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-HTO

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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