An interventional study of Corticosteroid Injection and Platelet Rich Plasma Joint Injection in Knee Osteoarthritis (OA), sponsored by LifeBridge Health. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by LifeBridge Health · Not applicable, Interventional, and Treatment
Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.
Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →LifeBridge Health is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
\~3 milliliters (mL) injection of autologous PRP prepared with the Magellan Autologous Concentration System, ISTO Biologics
Device: Platelet Rich Plasma Joint Injection
5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)
Drug: Corticosteroid Injection
5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)
\~3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics
Pain score VAS
Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Pain intensity that is calculated by measuring the distance from the "no pain" end of a line to a mark placed by the patient to indicate their current pain level. This will be measured at baseline, six weeks, and three months.
Time frame: Baseline, six weeks, and three months.
Pain Score NRS
Numeric Pain Rating Scale (NRPS) where patients are asked to rate their pain on a scale of 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain imaginable. This will be measured at baseline, six weeks, and three months.
Time frame: Baseline, six weeks, and three months.
Functional score KOOS
Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. KOOS is used for any knee pathology and was found to be useful in assessing patients of various age populations, ranging from young to elderly adults. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. This will be measured at baseline, six weeks, and three months.
Time frame: Baseline, six weeks, and three months.
Functional score WOMAC
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. The total WOMAC score is the sum of the three subscale scores, with a possible score range of 0-96. Higher scores indicate worse pain, stiffness, and functional limitations. This will be measured at baseline, six weeks, and three months.
Time frame: Baseline, six weeks, and three months.
Pain Medication Adherence
Measured by number of days until pain medication (acetaminophen) is not adequate.
Time frame: Baseline through three months.
Plan to share: Undecided
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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