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

Martina Hansen's Hospital

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: High tibial osteotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01797003

TKN-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Opening wedge HTO

Active Comparator group

Description:

Opening wedge high tibial osteotomy using Puddu plate

Treatment:

Other: High tibial osteotomy

Closing wedge HTO

Active Comparator group

Description:

Closing wedge high tibial osteotomy using cramp fixation

Treatment:

Other: High tibial osteotomy