Norwegican Cartilage Project - a study protocol for a double-blinded randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement in focal cartilage defects in the knee

BMC Musculoskeletal Disorders

Study Protocol

Jan Brinchmann¹  Per-Henrik Randsborg²  Einar Andreas Sivertsen³  Søren Vindfeld⁴  Håvard Visnes⁵  Tommy Frøseth Aae⁶  Anne Berg Breen⁷  Sverre Løken⁸  Heidi Andreassen Hanvold⁹  Asbjørn Årøen^1,10 

[1] Department of Immunology and Norwegian Center for Stem Cell Research, Oslo University Hospital, Rikshospitalet, Oslo, Norway;Department of Orthopedic Surgery, Akershus University Hospital, Lørenskog, Norway;Department of Orthopedic Surgery, Diakonhjemmet Hospital, Diakonveien, Norway;Department of Orthopedic Surgery, Haraldsplass Deaconess Hospital, Deaconess, Norway;Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway;Department of Orthopedic Surgery, Kristiansund Hospital, Kristiansund, Norway;Department of Orthopedic Surgery, Ålesund Hospital, Ålesund, Norway;Department of Orthopedics, Oslo University Hospital, Oslo, Norway;Department of Physiotherapy, Akershus University Hospital, Lørenskog, Norway;Institute of Clinical Medicine, University of Oslo, Oslo, Norway;Oslo Sports Trauma Research Centre, Norwegian School of Sport Sciences, Oslo, Norway;

关键词: Cartilage Defect;    Cartilage Lesion;    Autologous Chondrocyte Implantation;    Arthroscopic Debridement;    International Cartilage Repair Society;   

DOI  :  10.1186/s12891-016-1156-y

 received in 2016-06-08, accepted in 2016-07-02,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundFocal lesions to the articular cartilage in the knee might have demolishing consequences to the knee. There exists a wide range of possible surgical procedures targeting these injuries, however no significant differences have been found between these procedures. This may support that the improvement is a result of rehabilitation, and not the surgery itself. Arthroscopic microfracture (MF) treatment has gained popularity, and has become the treatment of choice in patients with knee cartilage defects globally. In this study we want to increase knowledge, both clinical and economic, about arthroscopic microfracture (AF) compared to arthroscopic debridement (AD) and physical rehabilitation both in the short run, and in the long run.Methods/DesignTo compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of focal cartilage lesions in the knee, a long-term, double-blinded, randomized controlled multicenter trial will be conducted. A total of 114 men and non-pregnant women with a symptomatic focal full thickness cartilage lesion in the knee less than 2 cm2 will be included in the study. The two treatment allocations will receive identical rehabilitation, which is made up of 3 phases: accommodation, rehabilitation and return to activity. Follow up is 24 months, where all will be invited to participate in late follow ups after 5 and 10 years.The Knee Injury and Osteoarthritis Outcome Score (KOOS) knee-related quality of life (QoL) subscore is the primary endpoint. Clinical parameters, questionnaires and radiologic modalities (Magnetic Resonance Imaging (MRI) and x-ray) will be used as secondary endpoints.DiscussionThis is an ongoing multicenter study with a high level of evidence to compare arthroscopic microfracture with arthroscopic debridement and physiotherapy for the treatment of isolated symptomatic full thickness cartilage lesions in the knee joint.Trial registrationClinicalTrials.gov ID: NCT02637505 (December 15, 2015).

【 授权许可】

CC BY   
© The Author(s). 2016