Weightbearing After High Tibial Osteotomy
|First Received Date ICMJE||January 23, 2007|
|Last Updated Date||May 1, 2013|
|Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Migration in mm measured with RSA (Roentgen Stereometric Analysis): [ Time Frame: Postoperative, at 3 month, 1 and 2 years. ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00426907 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Weightbearing After High Tibial Osteotomy|
|Official Title ICMJE||Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study.|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Osteoarthritis, Knee|
|Intervention ICMJE||Procedure: Unlimited postoperative weightbearing
Unlimited postoperative weightbearing
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||20|
|Completion Date||July 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Denmark|
|NCT Number ICMJE||NCT00426907|
|Other Study ID Numbers ICMJE||ON-04-016-TLH|
|Has Data Monitoring Committee||No|
|Responsible Party||Northern Orthopaedic Division, Denmark|
|Study Sponsor ICMJE||Northern Orthopaedic Division, Denmark|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Northern Orthopaedic Division, Denmark|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP