Autologous Cartilage Implantation vs Arthroscopic Debridement
NCT02636881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2024-09-25
Summary
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).
Conditions
- Knee Injury
- Cartilage Injury
Interventions
- PROCEDURE
-
Autologous Chondrocyte Implantation
Implantation of the patients own cartilage cells in a chondral defect of the knee
- PROCEDURE
-
Arthroscopic Debridement
Arthroscopic diagnosis and debridement of the lesion, without cartilage therapy. Removal of lose bodies etc.
Sponsors & Collaborators
-
University Hospital, Akershus
lead OTHER
Principal Investigators
-
Heidi Hanvold, PT · Research coordinator
-
asbjørn Årøen, MD, PhD · Akerhus University hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2022-09-30
- Completion
- 2022-09-30
Countries
- Norway
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