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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Other: High tibial osteotomy

• Registration Number: NCT01797003
• Lead Sponsor: Martina Hansen's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closing wedge HTO	High tibial osteotomy	Closing wedge high tibial osteotomy using cramp fixation
Opening wedge HTO	High tibial osteotomy	Opening wedge high tibial osteotomy using Puddu plate

Primary Outcome Measures

Name	Time	Method
Kne injury and Osteoarthritis Outcome Score (KOOS)	2 years postoperataively	The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively.

Secondary Outcome Measures

Name	Time	Method
Range of motion (ROM)	2 years postoperatively	The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively.

Trial Locations

Locations (1)

Martina Hansens Hospital; 🇳🇴 Oslo, Norway