Symptomatic chondral or osteochondral defect of the knee Musculoskeletal Diseases
Conditions
Interventions
Randomisation will be performed using a secure internet-based randomisation system ensuring allocation concealment. Trial participants will be randomised in a 1:1 ratio to receive either microfracture
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Data will be collected to characterise the following secondary outcomes over the 2-year follow up period: 1. Knee function assessed using International Knee Documentation Committee (IKDC) subjective knee evaluation score at 2 years (range 0-100 with 100 representing the best level of symptoms, function and activity). Domains include symptoms experienced over the last 1-4 weeks and when undertaking particular activities, including sporting activities and activities of daily living. It is reliable and validated with a minimal clinically important difference (MCID) of 9 points. This is collected using a questionnaire at baseline, 3, 6, 12 and 24 months. 2. Activity assessed using Tegner-Lysholm activity grading scale (range 0-100 with 100 representing the best level of function/activity). There are 8 questions based on ability or symptoms including limp, support, pain, instability, locking, swelling, stair-climbing and squatting. This is collected using a questionnaire at baseline, 3, 6, 12 and 24 months. 3. Health-related quality of life (HRQoL) assessed using EQ-5D-5L, a validated, generalised and standardised instrument comprising a visual analogue scale measuring self-rated health and a health status instrument of 5 domains related to daily activities. This instrument will be used to derived 2-year quality-adjusted life years (QALYs), by attaching UK preference-based utility indices to the EQ-5D-5L health states and weighting them with survival over time. This is collected using a questionnaire at baseline, 3, 6, 12 and 24 months. 4. Productivity assessed using Work Productivity and Activity Impairment (WPAI), a validated instrument which measures the impact of health and symptom severity on work productivity and non-work activities. Absenteeism and presenteeism will be valued using the human capital approach and estimates of average weekly earnings to estimate productivity losses for the economic eval | — |
Countries
England, United Kingdom
Contacts
Public ContactLucy Dabner
Outcome results
None listed