METHODS AND ANALYSIS: A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate.
ETHICS AND DISSEMINATION: The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings.
TRIAL REGISTRATION NUMBER: ACTRN12615000963527; Pre-results.
MATERIALS AND METHODS: A prospective study of patients undergoing cartilage repair with microfracture surgery and BST-CarGel at our institution from 2016 to 2019 was performed. Clinical outcomes were determined using the Lysholm Knee Scoring System and Knee Injury and Osteoarthritis Outcome Score (KOOS). These questionnaires were administered before the surgery and at a minimum of two years after surgery.
RESULTS: A total of 21 patients were identified and recruited into the study. 31 cartilage defects were seen and treated in 21 knees. These included horizontal lesions (e.g., trochlear, lateral tibial plateau), vertical lesions (e.g., medial femoral condyle, lateral femoral condyle) and inverted lesions (e.g., patella). No complications or reoperations were seen in our study population. For the average duration of follow-up of 42.5±8.55 months, there was an average improvement in Lysholm score of 25.8±18.6 and an average improvement in KOOS score of 22.5±15.0.
CONCLUSION: BST-CarGel with microfracture surgery using the AMIC technique is a safe and effective treatment for cartilage defects in the short to medium term.