Autologous Cartilage Implantation vs Arthroscopic Debridement (ACI)
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|ClinicalTrials.gov Identifier: NCT02636881|
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Injury Cartilage Injury||Procedure: Autologous Chondrocyte Implantation Procedure: Arthroscopic Debridement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Focal Cartilage Defects in the Knee -A Randomized Controlled Trial Comparing Autologous Chondrocyte Implantation With Arthroscopic Debridement|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Autologous Chondrocyte Implantation
A diagnostic arthroscopy of the knee joint.The lesion is stabilized down to the subchondral bone, but not through it. Cartilage biopsy is taken from the medial femoral notch. The harvested cartilage is transported to the cell culture Laboratory and cultured for two weeks. The chondrocyte implantation: A mini-open arthrotomy is performed and the lesion is curetted down to subchondral bone, avoiding bleeding. The lesion is measured and a template of sterile aluminum foil is used to cut out a matching piece of collagen sheet which is used to contain the cells in the defect. The flap is sutured to the lesion and sealed with fibrin glue, leaving and opening at the upper part for injection of the cells. The last opening is then closed with a last stitch and fibrin glue.
Procedure: Autologous Chondrocyte Implantation
Implantation of the patients own cartilage cells in a chondral defect of the knee
Sham Comparator: Arthroscopic Debridement
The AD group will be subjected to a diagnostic arthroscopy with a full inspection of the knee joint to ensure the inclusion criteria are fulfilled. Lose bodies are removed, any meniscal pathology is addressed. Inflamed synovium is debrided. The lesion is stabilized by debridement around the edges and down to the subchondral bone using a ring curette, but not through it. Microfracture or any other cartilage treatment will not be performed.
No intra-articular local anesthetics will be used due to the possible harmful effect on cartilage [41-43].
All the operating surgeons will receive proper training in the operative procedure before study start.
Procedure: Arthroscopic Debridement
Arthroscopic diagnosis and debridement of the lesion, without cartilage therapy. Removal of lose bodies etc.
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life [ Time Frame: 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.
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains [ Time Frame: preop, 3, 6, 12 and 24 months. ]The other four domains of the KOOS score (pain, symptoms, Activity of daily living, sport and recreational function) will act as secondary endpoints
- Tegner Score [ Time Frame: preop, 3, 6, 12 and 24 months. ]A validated knee-score to assess the Level of physical activity
- Lysholm Knee Score [ Time Frame: preop, 3, 6, 12 and 24 months. ]A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting
- EQ5D [ Time Frame: preop, 3, 6, 12 and 24 months. ]A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.
- Visual Analogue Scale [ Time Frame: preop, 3, 6, 12 and 24 months. ]VAS scale for pain from 0 to 10
- Range of motion [ Time Frame: preop, 3, 6, 12 and 24 months. ]Clinical evaluation of the joint range of motion
- Magnetic Resonance Imaging [ Time Frame: 24 months ]A radiographic evaluation of the cartilage injury at 2 years
- A Hop test [ Time Frame: 24 months ]Clinical evaluation of the knees agility, validated in knee sport medicine Research.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636881
|Contact: Per-Henrik Randsborg, PhD||+47 firstname.lastname@example.org|
|Contact: Asbjorn Aaroen, Professor||+47 email@example.com|
|Principal Investigator:||Heidi Hanvold, PT||Research coordinator|