Surgery for knee articular cartilage injuries

INTERVENTION: 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 of the chondral/osteochondral lesion with insertion of a bilayer collagen matrix microstructural scaffold or microfracture alone. Participants and clinical care teams (except for staff involved in the surgery) and members of the research team responsible for data collection will be blinded to allocation. Both groups will be followed for 2 years by clinical review to collect information about quality of life, symptoms and pain in the knee, complications of surgery, need for further surgery and costs to the NHS and patients. CONDITION: Symptomatic chondral or osteochondral defect of the knee ; Musculoskeletal Diseases PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: ; 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 evaluation. This is collected using a questionnaire at baseline, 3, 6, 12 and 24 months.; 5. Complications, including bleeding, infection, deep vein thrombosis or pulmonary embolism, need for further surgery (non‐joint replacement and joint replacement), collected on study case report forms by the research nurse.; 6. Resources required to i) deliver the two treatments, ii) treat short‐ and long‐term complications; iii) follow‐up care in hospital, including rehabilitation, outpatient appointments, A&E, and re‐admissions. Other health and social care resources required in the community and patient expenditures with their care will be collected from the participant using questionnaires at baseline, 3, 6, 12 and 24 months. Resources will be valued using Department of Health and Social Care reference costs, and national unit costs for health and social care, where available, or local sources otherwise.;