A Phase 4 interventional study of Unlimited postoperative weightbearing in Osteoarthritis, Knee, sponsored by Northern Orthopaedic Division, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Northern Orthopaedic Division, Denmark · Phase 4, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Full postoperative weightbearing
Procedure: Unlimited postoperative weightbearing
Partial weightbearing 6 weeks postoperative
Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing
Migration in mm measured with RSA (Roentgen Stereometric Analysis):
Time frame: Postoperative, at 3 month, 1 and 2 years.
Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
Time frame: Postoperative, at 3 month, 1 and 2 years.
Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
Time frame: 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.
Time frame: Postoperative, at 3 month, 1 and 2 years.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark