Northern Orthopaedic Division, Klinik Farsoe and Aarhus University Hospital
Farsø, Northern Jutland, Denmark
NCT Number: NCT00426907
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Farsø, Northern Jutland, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unlimited postoperative weightbearing
Time frame: Postoperative, at 3 month, 1 and 2 years.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Northern Orthopaedic Division, Denmark
Other
Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.
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