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Norwegian Cartilage Project - Microfracture

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ClinicalTrials.gov Identifier: NCT02637505
Recruitment Status : Recruiting
First Posted : December 22, 2015
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Kristiansund Hospital
Alesund Hospital
Haukeland University Hospital
Diakonhjemmet Hospital
Oslo University Hospital
Haraldsplass Deaconess Hospital
Information provided by (Responsible Party):
Asbjorn Aroen, University Hospital, Akershus

Brief Summary:
114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture 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 as well as clinical examination and radiological findings at 2 years (MRI).

Condition or disease Intervention/treatment Phase
Knee Injury Cartilage Injury Procedure: Arthroscopic microfracture (MF) Procedure: Arthroscopic debridement (AD) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
Study Start Date : January 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arthroscopic microfracture (MF)
The AM group will be subjected to a diagnostic arthroscopy with a full inspection of the knee joint to ensure the inclusion criteria are fulfilled. The cartilage is cut sharp forming a rim of 90 degrees. The calcified layer is removed using a curette before an arthroscopic awl is then used to perform multiple holes ("microfractures") from the periphery towards the center. The microfractures are 3 - 4 mm apart and 2 - 4 mm deep into the subchondral bone. The correct and successful technique is confirmed by direct visualization: while reducing the fluid pump pressure, the release of marrow fat droplets and blood will be observed.
Procedure: Arthroscopic microfracture (MF)
Arthroscopy With microfracture procedure

Sham Comparator: Arthroscopic debridement (AD)
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. The lesion is stabilized, debriding all loose or marginally attached cartilage from the surrounding rim to form a stable edge of healthy cartilage around the defect using a ring curette, where cartilage slops down to the defect.
Procedure: Arthroscopic debridement (AD)
Arthroscopy With debridement procedure




Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life [ Time Frame: 24 months follow up ]

    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 primary aim is where the primary aim is the difference in KOOS QoL subscore in the AM group compared to the AD group at 24 months follow up.

    It is not planned any interim analysis before 24 months follow up.



Secondary Outcome Measures :
  1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains [ Time Frame: 24 months follow up ]
    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: 24 months follow up ]
    A validated knee-score to assess the level of physical Activity.

  3. Lysholm Knee Score [ Time Frame: 24 months follow up ]
    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: 24 months follow up ]
    A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.

  5. Visual Analog Scale [ Time Frame: 24 months follow up ]
    A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable.

  6. Range of motion [ Time Frame: 24 months follow up ]
    Clinical evaluation of the joint range of motion

  7. Magnetic Resonance Imaging (MRI) of the cartilage defect [ Time Frame: 24 months follow up ]
    A radiographic evaluation (MRI) of the cartilage injury at 2 years, to evaluate which patients have adequate cartilage quality 2 years after surgery. The MRI will be taken with a cartilage specific protocol.

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



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Ages Eligible for Study:   18 Years to 50 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 less 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 clinically, and if uncertainty on HKA radiographs
  • Systemic arthritis
  • Previous cartilage surgery except OCD fixation
  • Obesity BMI > 30
  • Serious drig or alcohol abuse
  • Inability to answer questionnaires or partake in rehabilitation
  • Comorbidity that may influence surgery or rehabilitation
  • Pregnancy

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): NCT02637505


Contacts
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Contact: Asbjorn Aaroen, Professor +4791587140 asbjorn.aroen@medisin.uio.no
Contact: Per-Henrik Randsborg, PhD +4797040480 pran@ahus.no

Locations
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Norway
Ålesund Hospital Recruiting
Ålesund, Møre And Romsdal, Norway, 6017
Contact: Anne B Breen, M.D.         
Akershus University Hospital Recruiting
Lørenskog, Norway, 1478
Contact: Per-Henrik Randsborg, PhD         
Sponsors and Collaborators
University Hospital, Akershus
Kristiansund Hospital
Alesund Hospital
Haukeland University Hospital
Diakonhjemmet Hospital
Oslo University Hospital
Haraldsplass Deaconess Hospital
Investigators
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Principal Investigator: Tommy F Aae, MD National 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: NCT02637505     History of Changes
Other Study ID Numbers: 2015/2202
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Asbjorn Aroen, University Hospital, Akershus:
Articular cartilage
Focal cartilage injury
Focal cartilage injury in the knee
Knee cartilage
Microfracture
Debridement

Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Fractures, Stress
Leg Injuries
Fractures, Bone