Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study
Stopped early · Not applicable
Conditions studied: Knee Osteoarthritis
In brief
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment.
Key facts
- Study ID
- NCT03898388
- Run by
- Regenexx, LLC
- People needed
- 47
- Starts
- 2019-03-21
- Expected to finish
- 2022-03-30
- Last updated by the study team
- 2023-09-28
Who can join
Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1) Voluntary signature of the IRB approved Informed Consent 2) Unilateral or bilateral osteoarthritic male or female ages 35-85 3) Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint 4) Physical examination consistent with osteoarthritis in one knee joint 5) Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc.) 6) Is independent, ambulatory, and can comply with all post-operative evaluations and visits
You may not qualify if…
- 7) Knee injections of any type within 3 months prior to the study. 8) Knee surgery within 6 months prior to the study.
- Patient undergoing lavage with treatment
- Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) 11) Quinolone or statin-induced myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's compensation case 15) Currently involved in a health-related litigation procedure 16) Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of chronic opioid 21) Documented history of drug abuse within six months of treatment 22) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Where it is running
- Interventional Orthopedics of Atlanta — Atlanta, Georgia, United States
- Regenexx Des Moines — Des Moines, Iowa, United States
- Regenexx Las Vegas — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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