Closing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus Tomofix plate fixation. A randomised trial.
- Conditions
- randomised controlled trial
- Registration Number
- NL-OMON20412
- Brief Summary
High tibia osteotomy for osteoarthritis of the knee: a prospective randomized trial <br> Reinoud W. Brouwer (MD) , Sita M.A. Bierma-Zeinstra (PhD) , Tom M. van Raaij (MD), Jan A.N. Verhaar (PhD) [submitted] <br> Patella height and inclination of tibial plateau after High Tibial Osteotomy. The open versus the closed wedge technique. A randomised trial. <bR> Reinoud W. Brouwer (MD), Sita M.A. Bierma-Zeinstra (PhD), Abram J. van Koeveringe (PhD), Jan A.N. Verhaar (PhD) [J Bone Joint Surg Br. 2005 Sep;87(9):1227-32]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
1. Patients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty;
2. Above 18 years of age;
1. Mechanical axis not through the medial compartment (HipKneeAnkle angle > 180¢ª);
2. Rheumatoid arthritis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is the accuracy of achieved correction of the mechanical limb axis postoperatively compared to the preoperatively planned correction superior for closing wedge HTO with plate fixation? <br><br /><br /><br>Measurement:<br /><br>1. Conservation of corrected angular limb deformity one year after surgery (success rate (%)). (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).
- Secondary Outcome Measures
Name Time Method I- Does the functional outcome differ between the two bone defect implants?<br><br /><br /><br>Measurement:<br /><br>1. Knee range of motion (ROM);<br /><br>2. Pain score (Visual Analogue Scale);<br /><br>3. Hospital for Special Surgery (HHS) Knee Service Rating System;<br /><br>4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC);<br /><br>5. Health related quality-of-life score (EuroQol);<bR><br>6. Complication. <br><bR><br /><br>II - Which surgical technique is most efficient? <bR><br>Measurement:<br /><br>7. Cost efficiency.