Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
This trial is active, not recruiting.
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Opening wedge high tibial osteotomy using Puddu plate
Closing wedge high tibial osteotomy using cramp fixation
Kne injury and Osteoarthritis Outcome Score (KOOS)
time frame: 2 years postoperataively
Range of motion (ROM)
time frame: 2 years postoperatively
Male or female participants from 30 years up to 60 years old.
- Medial osteoarthritis in the knee (x-ray and arthroscopy)
- Pain in medial compartment of the knee
- Correction angle of 5 degrees or more
- Former or active infection in the knee
- Rheumatoid arthritis or other similar disease
- Neurological disease
- Kidney disease or metabolic disease
|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.|
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