Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage
Completed · Phase 1
Conditions studied: Knee Osteoarthritis
In brief
The purpose of this study is to understand how the components of osteoarthritic knee joint fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally, the study participants will complete outcome questionnaire surveys before and after the treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks after lavage). This data will help determine if the treatment of an osteoarthritic knee joint with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by preparing a patient's knee for further regenerative therapies.
Key facts
- Study ID
- NCT03120988
- Run by
- Regenexx, LLC
- People needed
- 10
- Starts
- 2016-07-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-07-17
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 institutional review board approved Informed Consent
- 2) 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 as observed on imaging
- 5) Unilateral or bilateral Kellgren-Lawrence grade 3 or greater knee osteoarthritis (moderate to severe OA) 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) Mild effusion upon ultrasound evaluation.
- 7) Is independent, ambulatory, and can comply with all postoperative evaluations and visits
You may not qualify if…
- 1) Knee injections of any type within 3 months prior to the study.
- 2) Knee surgery within 6 months prior to the study.
- 3) 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)
- 4) Quinolone or Statin induced myopathy/tendinopathy
- 5) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
- 6) Contraindications for MRI
- 7) Condition represents a worker's compensation case
- 8) Currently involved in a health-related litigation procedure
- 9) Is pregnant
- 10) Bleeding disorders
- 11) Currently taking anticoagulant or immunosuppressive medication
- 12)Allergy or intolerance to study medication
- 13)Use of chronic opioid
- 14)Documented history of drug abuse within six months of treatment
- 15)Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Where it is running
- Centeno-Schultz Clinic — Broomfield, Colorado, United States
Full record on ClinicalTrials.gov
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