Status:
COMPLETED
Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
Lead Sponsor:
Ohio State University
Conditions:
Osteoarthritis, Knee
Microfragmented Adipose Tissue
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
The study aims to conduct a randomized trial comparing the clinical outcomes of PRP (standard intervention) versus Microfragmented adipose tissue (investigational) for the treatment of knee osteoarthr...
Detailed Description
Background Knee osteoarthritis is a leading cause of disability worldwide. Standard of care treatments for knee OA include activity modification, weight loss, therapeutic exercise and injections like...
Eligibility Criteria
Inclusion
- Age 25-75 years
- BMI \< 40
- Diagnosis of knee OA (primary and post-traumatic)
- Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 1-4)
- Continued OA pain in the target knee despite at least 6 weeks of 1 of the following nonoperative treatments: activity modification, weight loss attempt, physical therapy, or NSAID / acetaminophen.
- Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65
- Working knowledge of English language (to be able to complete all outcome scores)
- Ability to attend all follow-up appointments
Exclusion
- Isolated patellofemoral OA
- 3+ effusion of the target knee (stroke test grading system)
- Significant (10 degree) valgus or varus deformities
- Prior injection therapy:
- Steroid injection in target knee in the last 3 months
- Viscosupplementation in target knee in the last 6 months
- PRP in the target knee in the last 1 year
- No other cellular treatments in index knee (bone marrow, amniotic suspensions etc) all time
- Participation in any experimental device or drug study within 1 year before screening visit
- Oral or IM steroids for last 3 months
- Medical condition that may impact outcomes of procedure including:
- anemia
- thrombocytopenia
- bleeding disorders
- inflammatory disorders like rheumatoid arthritis, lupus
- diabetes
- any history of cancer (other than non-melanoma skin malignancies)
- taking anticoagulants (aspirin, Plavix, eliquis, Xarelto, warfarin, lovenox)
- Taking immunosuppressants, having a severe systemic infection
- Previous cartilage repair procedure on the injured cartilage surface (ie, OATS, ACI, MFX)
- Previous surgery at the target knee within the past 1 year
- Any degree of cognitive impairment.
- OA of either hip
- Pregnancy, lactating, or intent to become pregnant during treatment period
- Gout
- History of infection or current infection at the affected joint
- Smoking
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04351087
Start Date
March 3 2020
End Date
July 5 2022
Last Update
August 9 2024
Active Locations (1)
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1
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221