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Platelet-rich Plasma (PRP) for Arthroscopic Surgery
N/A
Waitlist Available
Led By David Kulber, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; subjects will be followed for 12 months post arthroscopic debridement.
Awards & highlights
Study Summary
This trial will compare whether adding platelet-rich plasma to arthroscopic debridement helps heal TFCC tears better than just arthroscopic debridement.
Eligible Conditions
- Arthroscopic Surgery
- Triangular Fibrocartilage Complex Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; subjects will be followed for 12 months post arthroscopic debridement.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; subjects will be followed for 12 months post arthroscopic debridement.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Mayo Wrist Score - Functional Status Score
Modified Mayo Wrist Score - Grip Strength Score
Modified Mayo Wrist Score - Pain Score
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Platelet-rich Plasma (PRP) groupExperimental Treatment1 Intervention
Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with platelet-rich plasma (PRP) (24 subjects).
Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the platelet-rich plasma (PRP)is injected into the debrided wrist
Group II: Standard Treatment groupActive Control1 Intervention
Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with platelet-rich plasma (PRP)(24 subjects).
Intervention: No platelet-rich plasma (PRP) injection into debrided wrist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich Plasma (PRP)
2011
N/A
~120
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,853 Total Patients Enrolled
David Kulber, MDPrincipal InvestigatorCedars-Sinai
2 Previous Clinical Trials
75 Total Patients Enrolled
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