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High Tibial Osteotomy for Osteoarthritis of the Knee

NCT ID: NCT01977261

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Opening-wedge HTO

Opening-wedge high tibial osteotomy fixated with a Puddu-plate

Group Type EXPERIMENTAL

Opening-wedge HTO

Intervention Type PROCEDURE

Opening-wedge high tibial osteotomy fixated with a Puddu plate

Closing-wedge HTO

Closing-wedge high tibial osteotomy fixated with 2 staples

Group Type ACTIVE_COMPARATOR

Closing-wedge HTO

Intervention Type PROCEDURE

Closing-wedge high tibial osteotomy fixated with two staples

Interventions

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Opening-wedge HTO

Opening-wedge high tibial osteotomy fixated with a Puddu plate

Intervention Type PROCEDURE

Closing-wedge HTO

Closing-wedge high tibial osteotomy fixated with two staples

Intervention Type PROCEDURE

Other Intervention Names

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open wedge high tibial osteotomy Closed wedge high tibial osteotomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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T. Duivenvoorden

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus Medical Centre

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2001-HTO

Identifier Type: -

Identifier Source: org_study_id