Abstract
BackgroundArticular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). “Instant MSC Product accompanying Autologous Chondron Transplantation” (IMPACT) combines rapidly isolated recycled autologous chondrons with allogeneic MSCs in a one-stage surgery. IMPACT was successfully executed in a first-in-man investigator-driven phase I/II clinical trial in 35 patients. The purpose of this study is to compare the efficacy of IMPACT to nonsurgical treatment for the treatment of large (2–8 cm2) articular cartilage defects in the knee.MethodsSixty patients will be randomized to receive nonsurgical care or IMPACT. After 9 months of nonsurgical care, patients in the control group are allowed to receive IMPACT surgery. The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion. Cartilage formation will be assessed at baseline, and 6 and 18 months after inclusion using MRI. An independent rheumatologist will monitor the onset of a potential inflammatory response. (Severe) adverse events will be recorded. Lastly, the difference between IMPACT and nonsurgical care in terms of societal costs will be assessed by monitoring healthcare resource use and productivity losses during the study period. A health economic model will be developed to estimate the incremental cost-effectiveness ratio of IMPACT vs. nonsurgical treatment in terms of costs per quality adjusted life year over a 5-year time horizon.DiscussionThis study is designed to evaluate the efficacy of IMPACT compared to nonsurgical care. Additionally, safety of IMPACT will be assessed in 30 to 60 patients. Lastly, this study will evaluate the cost-effectiveness of IMPACT compared to nonsurgical care.Trial registrationNL67161.000.18 [Registry ID: CCMO]2018#003470#27 [EU-CTR; registered on 26 March 2019]NCT04236739 [ClinicalTrials.gov] [registered after start of inclusion; 22 January 2020]
Highlights
Background and rationale {6a} Cartilage defects are common knee injuries that lead to a deterioration of sports performance, increased work leave, and limitations in daily activities
This study is designed to evaluate the efficacy of Instant Mesenchymal stromal cells (MSC) Product accompanying Autologous Chondron Transplantation (IMPACT) compared to nonsurgical care
This study will evaluate the cost-effectiveness of Instant MSC Product accompanying Autologous Chondron Transplantation” (IMPA CT) compared to nonsurgical care
Summary
Background and rationale {6a} Cartilage defects are common knee injuries that lead to a deterioration of sports performance, increased work leave, and limitations in daily activities. ACI is a costly procedure due to the requirement of cell culture [13] and it has been unavailable in many European countries after different products have been withdrawn from the European market [14, 15]. Due to this limited availability, nonsurgical care consisting of physiotherapy and pain medication remains the treatment of choice. Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). The purpose of this study is to compare the efficacy of IMPACT to nonsurgical treatment for the treatment of large (2–8 cm2) articular cartilage defects in the knee
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