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Total or partial knee arthroplasty trial

Clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with medial compartment osteoarthritis: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03013488
Enrollment
500
Registered
2009-04-09
Start date
2010-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis/avascular necrosis Musculoskeletal Diseases Polyarthrosis

Interventions

Total knee replacement surgery versus unicompartmental knee replacement surgery. Patients will be followed up for 10 years post surgery. Going on the average waiting list times of 3 months, the approx

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Medial osteoarthritis with exposed bone on both femur and tibia or avascular necrosis 2. Functionally intact anterior cruciate ligament (superficial damage or splitting is acceptable) 3. Full thickness lateral cartilage 4. Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5. Medically fit showing an American Society of Anaesthesiologists (ASA) grade 1 or 2 6. Expectancy of over 10 years of active life 7. Aged 40 years or over, either sex

Exclusion criteria

Exclusion criteria: 1. Require revision knee replacement surgery 2. Have rheumatoid arthritis or other inflammatory disorders 3. Are likely to benefit from a specific prosthesis type 4. Are unlikely to be able to perform required clinical assessment tasks 5. Have symptomatic foot, hip or spinal pathology

Design outcomes

Primary

MeasureTime frame
Oxford Knee Score: a patient based validated and effective measure of change over time questionnaire. Both the absolute and the change scores will be analysed at 5- and 10-year points post-operation.

Secondary

MeasureTime frame
1. American Knee Society Score: to measure the range of motion and function of the knee, measured at 2 months, 1, 5 and 10 years post-surgery 2. UCLA Activity Score: to measure how active the patient is, measured at 2 months, 1, 5 and 10 years post-surgery 3. X-ray to check for immediate problems, assess the outcome of surgery, complications and make long-term predictions, measured at 2 months, 1, 5 and 10 years post-surgery 4. EQ-5D: to provide data for the economic evaluation, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery 5. Lund Score: to measure patient satisfaction, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery 6. Other outcomes, e.g., kinematic and gait assessments, measured at 2 months, 1, 5 and 10 years post-surgery

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026