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
|Condition or disease||Intervention/treatment||Phase|
|Knee Injury Cartilage Injury||Procedure: Arthroscopic microfracture (MF) Procedure: Arthroscopic debridement (AD)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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
- Tegner Score [ Time Frame: 24 months follow up ]A validated knee-score to assess the level of physical Activity.
- 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.
- 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.
- 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.
- Range of motion [ Time Frame: 24 months follow up ]Clinical evaluation of the joint range of motion
- 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.
- A Hop test [ Time Frame: 24 months follow up ]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): NCT02637505
|Contact: Asbjorn Aaroen, Professoremail@example.com|
|Contact: Per-Henrik Randsborg, PhDfirstname.lastname@example.org|
|Ålesund, Møre And Romsdal, Norway, 6017|
|Contact: Anne B Breen, M.D.|
|Akershus University Hospital||Recruiting|
|Lørenskog, Norway, 1478|
|Contact: Per-Henrik Randsborg, PhD|
|Principal Investigator:||Tommy F Aae, MD||National coordinator|