Focal Cartilage Defects in the Knee -A Randomized Controlled Trial Comparing Autologous Chondrocyte Implantation With Arthroscopic Debridement (ACI)

NCT02636881 NA COMPLETED

82 patients aged 18-49 years with an isolated focal cartilage defect in the knee will be randomized to either receive autologous cartilage implantation or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The Groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D (European Quality of Life 5 dimensions) as well as clinical examination and radiological findings at 2 years (MRI).

Details

Lead sponsor	University Hospital, Akershus
Phase	NA
Status	COMPLETED
Enrolment	28
Start date	2016-04
Completion	2022-09

Conditions

• Knee Injury
• Cartilage Injury

Interventions

• Autologous Chondrocyte Implantation
• Arthroscopic Debridement

Primary outcomes

• The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life — up to 24 months
  The KOOS is a validated patient oriented outcome measure validated to use in cartilage Research. It assesses five domains, and the Fifth domain (knee related quality of life) will be the primary endpoint in this study.

Countries

Norway