Closing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus TomoFix plate fixation - a randomised trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Closing wedge high tibial osteotomy: staples and cast fixation versus TomoFix plate fixation. CONDITION: Arthritis, osteoarthritis ; Musculoskeletal Diseases ; Polyarthrosis PRIMARY OUTCOME: Is the accuracy of achieved correction of the mechanical limb axis post‐operatively compared to the pre‐operatively planned correction superior for closing wedge HTO with plate fixation?; ; Measurement:; Conservation of corrected angular limb deformity 1 year after surgery (success rate [%]). (Surgery is successful when the femoral‐tibial axis 1 year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction.) SECONDARY OUTCOME: 1. Does the functional outcome differ between the two bone defect implants? Measurement:; 1.1. Knee range of motion (ROM); 1.2. Pain score (Visual Analogue Scale); 1.3. Hospital for Special Surgery (HHS) Knee Service Rating System; 1.4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC); 1.5. Health‐related quality‐of‐life score (EuroQol); 1.6. Complication ; 2. Which surgical technique is most efficient? Measurement: cost efficiency INCLUSION CRITERIA: 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 3. Patient is knowledgeable and able to understand the treatment consequences 4. Informed consent
Epistemonikos ID: 465c2e7ff76ef00ef7f47a5afcadc38b5d51100d
First added on: Aug 21, 2024