Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment (KneeOA)
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|ClinicalTrials.gov Identifier: NCT02848027|
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2016
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: Regenexx SD® procedure||Phase 3|
Single-center, laboratory blinded to include up to 400 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s.Initial study procedures include baseline evaluation of medical history, knee history, knee examination, medication use, MRI, and subject-reported outcomes.
Subjects will be enrolled within the 120 days prior to Regenexx® SD injection. A preoperative visit will occur at the time of enrollment. Collection of synovial fluid from the OA knee/s will serve as the experimental condition, i.e. the osteoarthritic knee.Each osteoarthritic subject will undergo withdrawal of knee joint synovial fluid for each knee being treated (0.3-0.5 ml) which will be analyzed by the research laboratory via multiplexed enzyme linked immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB) at pre-injection (2-8 days before Regenexx® SD treatment) and post-injection (2-8 days after Regenexx® SD). Documentation of osteoarthritic joint characteristics and injection procedure details will be recorded throughout the study.
The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.
Components of the synovial fluid will be correlated to post-treatment clinical outcomes, which include patient-reported questionnaires as well as assessment of post-injection complications, adverse events, re-injections and surgical interventions. Patient-reported clinical outcomes are comprised of the IKDC Subjective Knee Evaluation, the Lower Extremity Function Scale, Numeric Pain Scale and a Patient Reported Percent Improvement form.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Regenexx-SD procedure
Measure components of knee synovial fluid collected 2-4 days before and after Regenexx SD procedure
Biological: Regenexx SD® procedure
Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.
- Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure. [ Time Frame: 6 months after Regenexx-SD procedure ]Synovial fluid components include cytokine, matrix metalloproteinase levels, and catabolic cartilage breakdown products. These components of synovial fluid will be correlated to the following patient-reported outcomes 6 months after procedure: the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form.
- Comparison of synovial fluid contents [ Time Frame: fluid taken ~2-4 days before procedure and ~2-4 days after procedure ]Comparison of cytokine, matrix metalloproteinase concentration levels and cartilage breakdown product levels from pre-Regenexx SD treatment to post-Regenexx SD treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848027
|Study Director:||Neven Steinmetz, Ph.D.||Regenexx, LLC|
|Principal Investigator:||Christopher J Centeno, M.D.||Regenexx, LLC|