Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

NCT ID: NCT01797003

Last Updated: 2022-10-18

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2017-01-31

Brief Summary

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Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis.

Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

Detailed Description

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Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods.

Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.

In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Opening wedge HTO

Opening wedge high tibial osteotomy using Puddu plate

Group Type ACTIVE_COMPARATOR

High tibial osteotomy

Intervention Type OTHER

Closing wedge HTO

Closing wedge high tibial osteotomy using cramp fixation

Group Type ACTIVE_COMPARATOR

High tibial osteotomy

Intervention Type OTHER

Interventions

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High tibial osteotomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Medial osteoarthritis in the knee (x-ray and arthroscopy)
* Pain in medial compartment of the knee
* Correction angle of 5 degrees or more

Exclusion Criteria

* Former or active infection in the knee
* Rheumatoid arthritis or other similar disease
* Cancer
* Neurological disease
* Kidney disease or metabolic disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Martina Hansen's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tor Kjetil Nerhus

Consultant Orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tor Kjetil Nerhus, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant orthopaedic surgeon

Locations

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Martina Hansens Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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TKN-003

Identifier Type: -

Identifier Source: org_study_id

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