A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment

Stopped early

Conditions studied: Osteoarthritis, Knee

In brief

The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.

Key facts

Study ID

NCT02370823

Run by

Regenexx, LLC

People needed

20

Starts

2015-02-01

Expected to finish

2018-03-01

Last updated by the study team

2018-03-30

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary signature of the IRB approved Informed Consent
• Unilateral osteoarthritic male or female ages 35-85
• Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
• Physical examination consistent with osteoarthritis in one knee joint
• Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
• Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis
• Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
• Normal range of motion of the unaffected knee
• No sign of pain, swelling, and/or functional disability of the unaffected knee
• No history of acute injury in the unaffected knee
• Is independent, ambulatory, and can comply with all post-operative evaluations and visits

You may not qualify if…

• Knee injections of any type within 6 months prior to the study.
• 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)
• Quinolone or Statin induced myopathy/tendinopathy
• Symptomatic lumbar spine pathology (e.g. radicular pain)
• Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
• Contraindications for MRI
• Tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
• Condition represents a worker's compensation case
• Currently involved in a health-related litigation procedure
• Is pregnant
• Bleeding disorders
• Currently taking anticoagulant or immunosuppressive medication
• Allergy or intolerance to study medication
• Use of chronic opioid
• Documented history of drug abuse within six months of treatment
• 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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