Osteoarthritis
Conditions
Keywords
osteoarthritis, osteotomy, closing, opening, wedge, kne, tibia
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.
Interventions
Sponsors
South-Eastern Norway Regional Health Authority
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oxford knee score | 2 years | The change in Oxford score are followed at several time points the first 2 years. Patients will be evaluated with Oxford knee score, 3 months, 6 months, 1 year and 2 years postoperatively. |
| Lysholm score | 2 years postoperatively | The change in Lysholm score are followed at several time points the first 2 years. Patients will be evaluated with Lysholm, 3 months, 6 months, 1 year and 2 years postoperatively. |
| UCLA activity scale | 2 years postoperatively | The change in UCLA scale are followed at several time points the first 2 years. Patients will be evaluated with UCLA activity scale, 3 months, 6 months, 1 year and 2 years postoperatively. |
| Tegner Activity Score | 2 years postoperatively | The change in Tegner score are followed at several time points the first 2 years. Patients will be evaluated with Tegner score, 3 months, 6 months, 1 year and 2 years postoperatively. |
Countries
Norway
Outcome results
None listed