This trial is active, not recruiting.

Condition osteoarthritis
Treatment high tibial osteotomy
Sponsor Martina Hansen's Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date March 2007
End date January 2017
Trial size 70 participants
Trial identifier NCT01797003, TKN-003


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Opening wedge high tibial osteotomy using Puddu plate
high tibial osteotomy
(Active Comparator)
Closing wedge high tibial osteotomy using cramp fixation
high tibial osteotomy

Primary Outcomes

Kne injury and Osteoarthritis Outcome Score (KOOS)
time frame: 2 years postoperataively

Secondary Outcomes

Range of motion (ROM)
time frame: 2 years postoperatively

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

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

Additional Information

Official title Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
Principal investigator Tor Kjetil Nerhus, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Martina Hansen's Hospital.