Knee Osteoarthritis Clinical Trial
Official title:
Assessing Catabolic Marker Levels in the Knee Synovial Fluid Microenvironment After Lavage With Platelet Poor Plasma (PPP)
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.
The objective of this study is to quantify the levels of catabolic markers in osteoarthritic
(OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor
plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are
sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels
within the 6 week period of the study.
This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage
would be a suitable therapy for knee OA patients either as a stand-alone treatment or to
improve outcome by preparing a patient's knee microenvironment for further treatment with
cellular therapies. Incidence of post-operative complications, adverse events, re-injections,
and surgical intervention; change in pain score will be considered while determining these
direct and indirect associations upon completion of the PPP lavage treatment. Correlation of
subject reported clinical outcomes for the PPP lavage treatment will be evaluated to
determine whether the treatment provides beneficial clinical outcomes.
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