- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637505
Norwegian Cartilage Project - Microfracture
Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Focal cartilage defects in the knee - A randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement.
Clinical compare the effect of arthroscopic microfracture (MF) with arthroscopic debridement (AD) in patients with symptomatic full thickness knee cartilage injuries less than 2cm2.
Focal cartilage injuries in the knee might have devastating effect both in the short term and in the long term. Various surgical treatment options are available, with microfracture the most used technique globally. Meta-analysis and systematic reviews have required well-designed, long-term, multicenter studies to evaluate clinical outcomes of microfracture with the use of a "no treatment" group as a control group.
H0: There is no difference in KOOS QoL after AM or AD 24 months after surgery. H1: There is a difference in KOOS QoL after AM or AD 24 months after surgery.
Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS. Physical examination: range of motion and hop test. Radiology: x-ray and MRI of the knee.
Primary aim: KOOS quality of life (QoL) subscore.
Prospective, double-blinded parallel-group multicenter study with 2 treatment arms. Approx. 24 months inclusion and 24 months follow up. In total 4 years.
All will be invited to participate in late controls after 5 and 10 years.
6 Norwegian hospitals: Akershus University Hospital, Oslo University Hospital - Ullevaal, Kristiansund Hospital, Aalesund Hospital, Diakonhjemmet Hospital and Haukeland University Hospital.
114 patients Inclusion: age 18-50 years old, single symptomatic cartilage defect on femoral condyle or trochlea.
2 treatment groups with 57 patients in each group. Follow up after 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 6 weeks) and 24 months (± 8 weeks). All will be invited to participate in late controls after 5 and 10 years. If any unforeseen complication outside normal clinical practice occurs, the sponsor representative will be contacted as soon as possible with a parallel message to the local coordinators at the involved hospitals. During each follow up, there will be a case report form (CRF) regarding complications and safety.
A 5 mL venous blood sample will be drawn on the day of operation. The blood sample will be centrifuged before serum is pipetted in a sterile tube. The serum will be analyzed at Oslo University Hospital - Rikshospitalet on the cartilage biomarker microRNA-140 (miR-140).
If normal distribution, aims will be analyzed using linear mixed models (LMM), and the primary aim will be performed as a post hoc test for the LMM, similar to performing a two-sample t-test. If no normal distribution, analysis will be performed using Mann-Whitney U-test.
Detecting a difference of 10 with 80 percent Power, uing a standard deviation of 18, this yields 52 patients in each group. By adding 10% due to loss during follow-up, we therefore plan to include a total of 114 patients.
No interim analysis will be done. Monitor from Health Møre and Romsdal HF. The end of this study is 24 months after the last included patient.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asbjorn Aaroen, Professor
- Phone Number: +4791587140
- Email: asbjorn.aroen@medisin.uio.no
Study Contact Backup
- Name: Per-Henrik Randsborg, PhD
- Phone Number: +4797040480
- Email: pran@ahus.no
Study Locations
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Lørenskog, Norway, 1478
- Akershus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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Arthroscopy With microfracture procedure
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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.
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Arthroscopy With debridement procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
24 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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24 months follow up
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Tegner Score
Time Frame: 24 months follow up
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A validated knee-score to assess the level of physical Activity.
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24 months follow up
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Lysholm Knee Score
Time Frame: 24 months follow up
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A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting.
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24 months follow up
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EQ5D
Time Frame: 24 months follow up
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A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care.
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24 months follow up
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Visual Analog Scale
Time Frame: 24 months follow up
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A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable.
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24 months follow up
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Range of motion
Time Frame: 24 months follow up
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Clinical evaluation of the joint range of motion
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24 months follow up
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Magnetic Resonance Imaging (MRI) of the cartilage defect
Time Frame: 24 months follow up
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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.
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24 months follow up
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A Hop test
Time Frame: 24 months follow up
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Clinical evaluation of the knees agility, validated in knee sport medicine Research.
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24 months follow up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tommy F Aae, MD,PhD, National Coordinator
- Study Director: Øystein Lian, MD, Kristian sund sykehus
Publications and helpful links
General Publications
- Banitalebi H, Owesen C, Aroen A, Tran HT, Myklebust TA, Randsborg PH. Is T2 mapping reliable in evaluation of native and repair cartilage tissue of the knee? J Exp Orthop. 2021 Apr 28;8(1):34. doi: 10.1186/s40634-021-00350-1.
- Aae TF, Randsborg PH, Breen AB, Visnes H, Vindfeld S, Sivertsen EA, Loken S, Brinchmann J, Hanvold HA, Aroen A. Norwegican Cartilage Project - a study protocol for a double-blinded randomized controlled trial comparing arthroscopic microfracture with arthroscopic debridement in focal cartilage defects in the knee. BMC Musculoskelet Disord. 2016 Jul 16;17:292. doi: 10.1186/s12891-016-1156-y.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/2202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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