NCT04017949|CompletedFDA Drug
Do Knee Injections Offer Benefit With Knee Arthritis Pain
Viscosupplementation and Corticosteroid Knee Injections: Do They Offer Any Benefit in Improving Osteoarthritic Knee Pain
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Viscosupplementation and Corticosteroid Knee Injections: Do They Offer Any Benefit in Improving Osteoarthritic Knee Pain
Sponsor study identifier
observational
75
1 country
1
Study Start
August 21, 2019
Actual (reported)Primary Completion
March 1, 2020
Actual (reported)Study Completion
March 1, 2020
Actual (reported)Corticosteroid and viscosupplementation injections have been used for years to treat osteoarthritic pain in knees. Recent studies have varied in reporting the effectiveness with these injections. None have been found to analyze pain scores between the groups though. This study aims to evaluate the effectiveness of corticosteroid injection (a single injection of 1 cc of 40 mg kenalog: 4 cc 0.5% Naropin) and viscosupplementation injection (Euflexxa and Synvisc, both are 2 cc of the medication given in 3 injections over a 3 week period). This will be analyzed with a modified visual analog scale over a period of time. An initial VAS will be collected prior to the first injection in the clinic. With the viscosupplementation injections, a VAS will be collected prior to injections 2 and 3 as well. These VAS are logged in the patient's chart. For both types of injections, the participant will be called and a VAS will be recorded 6 weeks post injection and 3 month post injection. These VAS will NOT be logged in the participant's chart. All VAS will be collected/recorded by the principal investigator. Statistical analysis will be conducted with a paired t-test (p\<0.05 with a confidence interval at 95%) from the pre-injection VAS and VAS subsequently.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 9, 2019
Actual (reported)July 12, 2019
Actual (reported)August 21, 2019
Actual (reported)March 1, 2020
Actual (reported)March 1, 2020
Actual (reported)Change from baseline in visual analog score at 3 months
The primary endpoint is significant improvement in visual analog scores for corticosteroid vs viscosupplementation injections pre- and post-injections. VAS scores range from 0-10, 0 being no pain, 10 being the worst pain imaginable. The hypothesis is the injections will help reduce the participant's perception of pain, resulting in lower VAS scores. If the power size is valid, VAS will be compared between males/females.
3 months
1 cc (40 mg) of a corticosteroid (kenalog) is given
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants will be recruited at their office visit scheduled with the principal investigator. Prior to the office visit, one of the surgeons diagnosed the potential subject with knee osteoarthritis. They recommended proceeding with a particular knee injection based upon previous treatments and insurance authorization. The determination of which injection is administered is not being determined by the study need.
Three Rivers Orthopedic Associates
Pittsburgh, Pennsylvania, 15215, United States
William J Vascik, MPAS, PA-C
Senior Physician Assistant
75 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2019
First Posted
July 12, 2019
Study Start
August 21, 2019
Actual (reported)Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis.
Contact the study team to confirm eligibility.
Primary Completion
March 1, 2020
Actual (reported)Study Completion
March 1, 2020
Actual (reported)Last Updated
April 6, 2020
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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