Efficacy of one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT) compared to nonsurgical treatment for focal articular cartilage lesions of the knee: study protocol for a crossover randomized controlled trial.

Autor: Korpershoek JV; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands., Vonk LA; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Present Address: CO.DON AG, Warthestraße 21, D-14513, Teltow, Germany., Kester EC; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands., Creemers LB; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands., de Windt TS; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands., Kip MMA; Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Technohal, Hallenweg 5, 7522, NH, Enschede, The Netherlands., Saris DBF; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.; Department of Orthopedic Surgery and Sports Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA., Custers RJH; Department of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands. r.j.h.custers@umcutrecht.nl.
Jazyk: angličtina
Zdroj: Trials [Trials] 2020 Oct 09; Vol. 21 (1), pp. 842. Date of Electronic Publication: 2020 Oct 09.
DOI: 10.1186/s13063-020-04771-8
Abstrakt: Background: Articular 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 cm 2 ) articular cartilage defects in the knee.
Methods: Sixty 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.
Discussion: This 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 Registration: NL67161.000.18 [Registry ID: CCMO] 2018#003470#27 [EU-CTR; registered on 26 March 2019] NCT04236739 [ ClinicalTrials.gov ] [registered after start of inclusion; 22 January 2020].
Databáze: MEDLINE
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