A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Regenexx, LLC
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Median change in protein concentration or percentage of cellular subpopulations
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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 (day 0). Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Median change in protein concentration or percentage of cellular subpopulations
Time Frame: 6 weeks compared to baseline
A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment.
Secondary Outcomes
- Mean Change in IKDC Scores from baseline to 6 weeks(6 weeks)
- Mean Change in Pain Scale from baseline to 6 weeks(6 weeks)
- Incidence and time to resolution of post-operative complications and adverse events(6 weeks)
- Incidence and time to re-injection/re-operation(6 weeks)