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Biological
A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries (TFCC Trial)
N/A
Waitlist Available
Led By John C Dunn
Research Sponsored by William Beaumont Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-injection, 2 weeks, 3 months, 6 months, 12 months
Summary
This trial is testing PRP therapy, which uses a patient's own blood to create a healing injection, on patients with wrist injuries called TFCC tears. The goal is to see if PRP can help these injuries heal faster and reduce pain. Platelet-rich plasma (PRP) is a recently developed technique that uses a concentrated portion of a patient's own blood to try to improve and accelerate the healing of various tissues.
Eligible Conditions
- Wrist Injuries
- Platelet Rich Plasma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-injection, 2 weeks, 3 months, 6 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-injection, 2 weeks, 3 months, 6 months, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disability of the Army Shoulder Hand (DASH)
Secondary study objectives
Mayo Wrist Score (Mayo)
Michigan Hand Outcome Questionnaire (MHOQ
Pain Anxiety Symptom Scale (PASS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental - PRP injectionExperimental Treatment1 Intervention
2cc of PRP is injected into the ulnocarpal joint
Group II: control - Saline injectionPlacebo Group1 Intervention
2cc of 0.9% sterile saline is injected into the ulnocarpal joint
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet-rich plasma (PRP)
2009
Completed Early Phase 1
~10
Find a Location
Who is running the clinical trial?
William Beaumont Army Medical CenterLead Sponsor
16 Previous Clinical Trials
2,304 Total Patients Enrolled
John C DunnPrincipal InvestigatorWBAMC Staff Hand Surgeon