Cartilage Injury Clinical Trial
Official title:
Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
Verified date | August 2023 |
Source | University Hospital, Akershus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 66 |
Est. completion date | September 28, 2022 |
Est. primary completion date | September 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lørenskog |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | Alesund Hospital, Diakonhjemmet Hospital, Haraldsplass Deaconess Hospital, Haukeland University Hospital, Kristiansund Hospital, Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life | 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 | The Knee Injury and Osteoarthritis Outcome Score (KOOS) Other domains | The other four domains of the KOOS score (pain, symptoms, Activity of daily living, sport and recreational function) will act as secondary endpoints | 24 months follow up | |
Secondary | Tegner Score | A validated knee-score to assess the level of physical Activity. | 24 months follow up | |
Secondary | Lysholm Knee Score | A condition specific knee score that assesses 8 domains: limp, locking, swelling, pain, stair climbing, use of support, instability and squatting. | 24 months follow up | |
Secondary | EQ5D | A generic measure of health status that produces a simple descriptive profile of Health status used in clinical evaluation of Health care. | 24 months follow up | |
Secondary | Visual Analog Scale | A visual analogue scale for pain, where 0 represents no pain and 10 represents the worst pain imaginable. | 24 months follow up | |
Secondary | Range of motion | Clinical evaluation of the joint range of motion | 24 months follow up | |
Secondary | Magnetic Resonance Imaging (MRI) of the cartilage defect | 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. | 24 months follow up | |
Secondary | A Hop test | Clinical evaluation of the knees agility, validated in knee sport medicine Research. | 24 months follow up |
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