Status:
ENROLLING_BY_INVITATION
Orthobiologic Treatment for Knee Osteoarthritis
Lead Sponsor:
University Hospital of North Norway
Conditions:
Osteoarthritis Knee
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are...
Detailed Description
Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically...
Eligibility Criteria
Inclusion
- Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale
- Age 40-70 years
- Minimum VAS 3
- No use of NSAIDs or steroids the last 14 days
- No injections of hyaluronic acid the last three months
- Varus/valgus deformity \<5 degrees as evaluated on x-ray imaging
Exclusion
- Pregnant or breastfeeding women
- Cancer
- Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)
- Previous knee surgery on the affected knee
- Secondary osteoarthritis in the knee
- Previous infection in the knee
- Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)
- Patients with a high risk of deep vein thrombosis
- Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06893250
Start Date
September 23 2024
End Date
December 1 2027
Last Update
March 25 2025
Active Locations (1)
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1
University Hospital in Northern Norway
Tromsø, Tromsø, Norway, 9038