Comparing cartilage cell transplantation with that of wash-out of the knee and physical therapy for patients with painful cartilage injuries to the knee. A controlled and randomized trial with two year follow up.
- Conditions
- Symptomatic focal cartilage defects in the kneeTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-000784-16-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Age 18-50 years old
-Single symptomatic cartilage defect on medial or lateral femoral condyle or trochlea
-Defect size larger than 2 cm2
-Defect ICRS grade 3-4
-Ligamentous stable knee
-Acceptable range of motion (minimum 5-105 °)
- Lysholm score < 75
-Informed consent
-Meniscus > 50 % intact
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 82
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
-Osteoarthritis, rheumatoid or other systemic arthritis (asked)
-Malalignment > 5° measured on HKA x-rays
-No radiological osteoarthritis
-Obesity (Body mass index > 30)
-Comorbidities that may influence surgery or rehabilitation
-Pregnancy
-Inability to complete questionnaires or rehabilitation
-Serious alcohol or drug abuse
- Previous cartilage surgery to the chondral defect except OCD surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method