N/A
Completed N=71
Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
Osteoarthritis, Knee · Microfragmented Adipose Tissue · Platelet-Rich Plasma
Source: ClinicalTrials.gov NCT04351087 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: KOOS Pain [Knee Injury and Osteoarthritis Outcome Score] — 79.95; 77.78 units on a scale — p=0.69
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 osteoarthritis.
Hypothesis: Both interventions will result in significant improvement in patient-reported outcomes. We hypothesize that Microfragmented adipose tissue will provide superior outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY KOOS Pain [Knee Injury and Osteoarthritis Outcome Score] |
79.95; 77.78 | 0.69 |
| SECONDARY VAS [Visual Analog Pain Scale] Pain Score |
1.6; 1.4 | — |
| SECONDARY Tegner Activity Scale |
3.9; 4.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04351087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.