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Completed

NCT Number: NCT01977261

High Tibial Osteotomy for Osteoarthritis of the Knee

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Centre

Rotterdam, 3015 CE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opening-wedge HTO

Procedure

Opening-wedge high tibial osteotomy fixated with a Puddu plate

Other names: open wedge high tibial osteotomy

Closing-wedge HTO

Procedure

Closing-wedge high tibial osteotomy fixated with two staples

Other names: Closed wedge high tibial osteotomy

Primary outcomes

  1. 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

  1. Severity of pain

    Time frame: one year

    Severity of pain will be measured with the visual analogue scale

  2. Knee function

    Time frame: one year

    Knee function will be measured with the Hospital for Special Surgery score

  3. Walking distance

    Time frame: one year

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: HTO

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Nov 6, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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