Weightbearing After High Tibial Osteotomy

Study Overview
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Brief Summary
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In this project we want investigate the clinical results after different rehabilitation regimens(Limited or unlimited weightbearing after surgery) in Open-wedge High Tibial Osteotomies. The hypothesis is that unlimited weightbearing is beneficial for the healing and rehabilitation.

Detailed Description
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In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient. However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation. Different rehabilitation-regimens are described, many advocating a period of partial weight-bearing for a period after surgery. Results from biomechanical studies suggest that immediate full weight-bearing is safe, enabling earlier mobilisation without compromising safe solid healing. The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies (osteosynthesis with the Dynafix® system (EBI)) after 2 different rehabilitation regimens: Limited weight-bearing (20 kg) for 6 weeks, and unrestricted weight-bearing. The investigation is performed as a randomised prospective clinical trial including 20 patients with a planned 2 years follow-up period. Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score. Routine standing x-rays is performed. Stability of the osteotomy is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

Official Title
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Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Unlimited postoperative weightbearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2 Varus deformity Exclusion Criteria: Prednisolone treatment. NSAID treatment. BMI > or = 35. Previous surgery in lateral knee compartment. Secondary Arthrosis following fracture(s) of the tibial condyle(s). Lack of informed consent. Correction >12,5 mm Peroperative displaced fracture of lateral bony hinge.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Full postoperative weightbearing | Procedure: Unlimited postoperative weightbearing<br>* Unlimited postoperative weightbearing<br>|
| Active Comparator: 2<br>Partial weightbearing 6 weeks postoperative | Procedure: Unlimited postoperative weightbearing<br>* Unlimited postoperative weightbearing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration in mm measured with RSA (Roentgen Stereometric Analysis): |  | Postoperative, at 3 month, 1 and 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative. |  | Postoperative, at 3 month, 1 and 2 years. | 
| Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative. |  | Postoperative, at 3 month, 1 and 2 years. | 
| Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop. |  | Postoperative, at 3 month, 1 and 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Osteotomy, Healing, Rehabilitation, Roentgen Stereometric Analysis