Total or partial knee arthroplasty trial

Not Applicable

Completed

• Conditions: Osteoarthritis/avascular necrosis; Musculoskeletal Diseases; Polyarthrosis

• Registration Number: ISRCTN03013488
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/24028414 2. 2017 early results in https://www.arthroscopyjournal.org/article/S0749-8063(17)30895-2/fulltext (added 13/05/2019) 3. 2019 5-year results in https://www.ncbi.nlm.nih.gov/pubmed/31326135 (added 22/07/2019) 4. 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32369436 (added 06/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-09
• Study Completion: 2018-12-31
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 528

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 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<br> 2. UCLA Activity Score: to measure how active the patient is, measured at 2 months, 1, 5 and 10 years post-surgery<br> 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<br> 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<br> 5. Lund Score: to measure patient satisfaction, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery<br> 6. Other outcomes, e.g., kinematic and gait assessments, measured at 2 months, 1, 5 and 10 years post-surgery<br>