Medial compartment knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
In this study, patients under 60 years old with knee OA who the treating orthopaedic surgeon considers a suitable candidate for medial opening wedge high tibial osteotomy (HTO) surgery will be selecte
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged <60 years old with symptomatic medial compartment knee OA who the treating orthopaedic surgeon considers a suitable candidate for medial opening wedge HTO
Exclusion criteria
Exclusion criteria: 1. Aged 60 years old 2. Body mass index (BMI) >40 3. Patients considered for HTO but who DO NOT have any knee OA including: 3.1. Offloading HTO for concomitant cartilage repair (No OA) 3.2. Offloading HTO solely to treat ligamentous instability (ACL/PCL) 3.3. Symptomatic avascular necrosis/osteonecrosis 3.4. Correction of intraarticular or extraarticular post-traumatic knee deformity 4. Patients requiring double-level knee osteotomy for correction of deformity 5. History of inflammatory arthropathy including rheumatoid arthritis, gout, psoriasis 6. Previous high tibial or distal femoral osteotomy in the same or contralateral knee 7. Previous knee replacement (partial or total) in the same or contralateral knee 8. Cognitive impairment or inability to consent. 9. Inability to comply with study procedures. 10. Previous history of septic arthritis in the knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' opinions about their knee and associated problems measured using the patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fidelity of interventions measured using the minimum requirements/acceptable variation (MRAV) proforma completed between 6 -12 months post-intervention (note that this interval may be different from the same period post-randomisation due to NHS waiting lists) 2. Patients' opinions about their knee and associated problems measured using the patient-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months post-randomisation. 3. Symptoms, pain, ADLs, sports/recreation, and quality of life measured using five separate KOOS subscales at 12- and 24-months post-randomisation 4. Function and pain measured using the Oxford Knee score (OKS) at 12 and 24- months post-randomisation 5. Artificial prosthesis awareness during daily activities measured using the Forgotten Joint Score-12 (FJS-12) at 12- and 24- months post-randomisation 6. Health-related quality of life measured using the EuroQol EQ-5D-5L score (EQ-5D-5L – EQ-5D) at 12- and 24- months post-randomisation 7. Sleep quality measure using the Pittsburgh Sleep Quality Index (PSQI) at 12- and 24-months post-randomisation 8. Employment status measured using a bespoke Return to Work/Employment Questionnaire developed at the lead centre at 12 and 24 months post-randomisation 9. Additional study-knee-related operative intervention measured using patient medical records at 12- and 24-months post-randomisation 10. Intraoperative and postoperative complications measured using patient medical records at 12 and 24 months post-randomisation 11. Health Economic Evaluation Outcomes derived from the EQ-5D score at 12- and 24- months post-randomisation 11.1. Health and social care resource utilisation and associated NHS and personal social services (PSS) cost and Quality Adjusted life years (QALY) at 24 months 11.2. Incremental Cost per QALY at 24 months 11.3. NHS and PSS cost, and QALYs as modelled over a lifetime horizon to account for future impacts on the need for TKR and associated revision surgery and their t | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactRachel Penman
Outcome results
None listed