Surgery for knee articular cartilage injuries

Not Applicable

• Conditions: Symptomatic chondral or osteochondral defect of the knee; Musculoskeletal Diseases

• Registration Number: ISRCTN90992837
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-06
• Study Completion: 2022-10-25
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 18 years of age or older
2. Symptomatic chondral or osteochondral defect of the knee sited on the medial or lateral femoral condyles, trochlea or patella as confirmed by standard clinical practice
3. Chondral or osteochondral lesion measuring no more than 4 cm2

Exclusion Criteria

Current participant exclusion criteria as of 12/08/2021:
1. Unstable, ligamentous injury to the knee that will not be treated
2. Unstable, meniscal tear that will not be treated
3. Less than 50% of native meniscal volume remaining in the knee following previous meniscal surgery
4. Knee alignment that in the opinion of the surgeon requires realignment surgery/osteotomy
5. Chondral or osteochondral lesion measuring >4 cm² following operative debridement of the lesion to a stable chondral rim
6. Chondral or osteochondral lesion that is being treated has been treated previously with one of the study interventions
7. Defects occurring on the tibial chondral surface
8. Patient unable/unwilling to adhere to trial procedures
9. Unable to provide written informed consent
10. Prisoners
11. Enrolled in another clinical trial and:
11.1. Co-enrolment is not permitted by the other trial
11.2. Co-enrolment would be burdensome for the patient
11.3. The intervention of the other trial could interfere with the SISMIC primary outcome

Previous participant exclusion criteria:
1. Unstable, untreated ligamentous injury to the knee
2. Unstable, untreated meniscal tear
3. Less than 50% of native meniscal volume remaining in the knee following previous meniscal surgery
4. Knee alignment that in the opinion of the surgeon requires realignment surgery/osteotomy
5. Chondral or osteochondral lesion measuring >4 cm2 following operative debridement of the lesion to a stable chondral rim
6. The chondral or osteochondral lesion that is being treated has previously been treated with either of the study interventions
7. Defects occurring on the tibial chondral surface
8. Patient unable/unwilling to adhere to trial procedures
9. Unable to provide written informed consent
10. Prisoners
11. Enrolled in another clinical trial and: a) co-enrolment is not permitted by the other trial; or b) co-enrolment would be burdensome for the patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Articular cartilage repair outcome assessed using participant-reported Knee injury and Osteoarthritis Outcome Score (KOOS) collected using a questionnaire at baseline, 3, 6, 12 and 24 months