Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.
This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis
Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.
Aestique Ambulatory Surgical Center
Greensburg, Pennsylvania, United States
DNA Advanced Pain Treatment
Greensburg, Pennsylvania, United States
Safety - Incidence of Treatment-Emergent Adverse Events
Subjects will be monitored for adverse events
Time frame: 6 months
Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits
Patient outcomes for pain will be recorded
Time frame: 1 week, 6 weeks, 3 months, and 6 months
Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits
Patient outcomes for function will be recorded
Time frame: 1 week, 6 weeks, 3 months, and 6 months
Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits
Patient outcomes for stiffness will be recorded
Time frame: 1 week, 6 weeks, 3 months, and 6 months
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