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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
Sponsor:
Information provided by (Responsible Party):
Asbjorn Aroen, University Hospital, Akershus

Brief 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).

Condition or disease Intervention/treatment Phase
Knee Injury Cartilage Injury Procedure: Autologous Chondrocyte Implantation Procedure: Arthroscopic Debridement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Tegner Score [ Time Frame: preop, 3, 6, 12 and 24 months. ]
    A validated knee-score to assess the Level of physical activity

  3. 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

  4. 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.

  5. Visual Analogue Scale [ Time Frame: preop, 3, 6, 12 and 24 months. ]
    VAS scale for pain from 0 to 10

  6. Range of motion [ Time Frame: preop, 3, 6, 12 and 24 months. ]
    Clinical evaluation of the joint range of motion

  7. Magnetic Resonance Imaging [ Time Frame: 24 months ]
    A radiographic evaluation of the cartilage injury at 2 years

  8. A Hop test [ Time Frame: 24 months ]
    Clinical evaluation of the knees agility, validated in knee sport medicine Research.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single symptomatic lesion of the trochlea, medial or lateral femoral condyle of the knee larger than 2 cm2.
  • Cartilage lesion ICRS grade 3 or 4.
  • More than 50 % of the menisci intact.
  • Ligamentous stable knee
  • Lysholm Score < 75
  • Acceptable range of motion (5-105 degrees)

Exclusion Criteria:

  • Osteoarthritis
  • Malalignment > 5 degrees measured on HKA (hip-knee-ankle) radiographs
  • Systemic arthritis
  • Previous cartilage surgery
  • Obesity BMI > 30
  • Serious drig or alcohol abuse
  • Inability to answer questionnaires or partake in rehabilitation
  • Comorbidity that may influence surgery or rehabilitation

Information from the National Library of Medicine

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


Contacts
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Contact: Per-Henrik Randsborg, PhD +47 97040480 pran@ahus.no
Contact: Asbjorn Aaroen, Professor +47 91587140 asbjorn.aroen@medisin.uio.no

Locations
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Norway
Akershus University Hospital Recruiting
Lørenskog, Oslo, Norway, 0587
Contact: Per-Henrik Randsborg, PhD MD    +4797040480    pran@ahus.no   
Contact: Asbjørn Årøen, PhD MD    +4791587140    asbjorn.aroen@uio.no   
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Principal Investigator: Heidi Hanvold, PT Research coordinator
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asbjorn Aroen, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02636881    
Other Study ID Numbers: 2015/2200
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Leg Injuries