title: Focal cartilage defects in the knee - a randomized controlled trial comparing autologous chondrocyte implantation with arthroscopic debridement.
abstract: BACKGROUND
  Focal cartilage injuries in the knee might have devastating effect due to the predisposition of early onset osteoarthritis. Various surgical treatment options are available, however no statistically significant differences have been found between the different surgical treatments. This supports the suggestion that the improvement might be a result of the post-operative rehabilitation rather than the surgery itself. Autologous chondrocyte implantation (ACI) has become a recognized treatment option for larger cartilage lesions in the knee. Although ACI has been compared to other surgical treatment such as microfracture and mosaicplasty, it has never been directly compared to simple arthroscopic debridement and rehabilitation alone. In this study we want to increase clinical and economic knowledge about autologous chondrocyte implantation compared to arthroscopic debridement and physical rehabilitation in the short and long run.
  
  
  METHODS
  We will conduct a randomized controlled trial to compare ACI with simple arthroscopic debridement (AD) and physiotherapy for the treatment of cartilage lesions in the knee. The study will include a total of 82 patients, both men and non-pregnant women, with a full thickness cartilage defect in the weight bearing area of the femoral condyles or trochlea larger than 2 cm2. The lesion must be symptomatic, with a Lysholm score less than 75. The two treatment groups will receive identical rehabilitation protocol according to a modification of Wondrasch et al., which is an active rehabilitation and education program divided into 3 phases: accommodation, rehabilitation and return to activity. The patients will be followed for 24 months, with additional late follow-ups at 5 and 10 years to monitor the potential onset of osteoarthtitis. The primary outcome measure will be the difference in the KOOS knee-related quality of life (QoL) subscore in the ACI group compared to the AD group at 2 years. A combination of self-explanatory questionnaires, clinical parameters, clinical hop tests and radiographs and Magnetic Resonance Imaging (MRI) will be used as secondary endpoints.
  
  
  CONCLUSIONS
  This is the first study with a high level of evidence to compare ACI with simple debridement and physiotherapy for the treatment of isolated symptomatic full thickness lesions of the knee.
  
  
  BACKGROUND
  ClinicalTrial NCT02636881 (21 December 2015).
authors.affiliation: Department of Orthopedic Surgery, Akershus University Hospital, Lørenskog, Norway. pran@ahus.no.
authors.forename: Per-Henrik
authors.initials: PH
authors.lastname: Randsborg
authors.affiliation: Department of Immunology and Norwegian Center for Stem Cell Research, Oslo University Hospital, Rikshospitalet, Oslo, Norway. Jan.Brinchmann@rr-research.no.
authors.forename: Jan
authors.initials: J
authors.lastname: Brinchmann
authors.affiliation: Department of Orthopedics, Oslo University Hospital, Oslo, Norway. s-loek@online.no.
authors.forename: Sverre
authors.initials: S
authors.lastname: Løken
authors.affiliation: Department of Physiotherapy, Akershus University Hospital, Lørenskog, Norway. hiad@ahus.no.
authors.forename: Heidi Andreassen
authors.initials: HA
authors.lastname: Hanvold
authors.affiliation: Department of Orthopedic Surgery, Kristiansund Hospital, Kristiansund, Norway. Tommy.Froseth.Aae@helse-mr.no.
authors.forename: Tommy Frøseth
authors.initials: TF
authors.lastname: Aae
authors.affiliation: Institute of Clinical Medicine, University of Oslo, Oslo, Norway. asbjorn.aroen@medisin.uio.no.|Oslo Sports Trauma Research Centre, Norwegian School of Sport Sciences, Oslo, Norway. asbjorn.aroen@medisin.uio.no.
authors.forename: Asbjørn
authors.initials: A
authors.lastname: Årøen
mesh_terms: D000293:Adolescent; D000328:Adult; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D001182:Arthroscopy / Q000009:adverse effects; D002358:Cartilage, Articular / Q000000981:diagnostic imaging / Q000601:surgery*; D002478:Cells, Cultured; D019902:Chondrocytes / Q000637:transplantation*; D002985:Clinical Protocols; D003646:Debridement / Q000009:adverse effects / Q000379:methods*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009664:Norway; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D026741:Physical Therapy Modalities; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult