Status:
TERMINATED
Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Arthroscopic Surgery
Triangular Fibrocartilage Complex Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare outcomes and functionality measures of subjects treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular fibrocartilage complex (T...
Detailed Description
Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with arthroscopic debridement, as is standard of care, followed by treatment with platelet rich plasma (PRP) (24 sub...
Eligibility Criteria
Inclusion
- Male or Female \>18 years of age
- triangular fibrocartilage complex (TFCC) tear requiring surgical intervention
- Be willing to undergo arthroscopic debridement and injection with platelet-rich plasma (PRP)
- Be in good health other than the TFCC tear
- Have realistic expectations of surgical results
- Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
Exclusion
- Have collagen-vascular, connective tissue, or bleeding disorders
- Be a smoker or have smoked in last 2 months
- Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- Have regional sympathetic dystrophy
- Be pregnant, lactating or expecting to be within the next 24 months
- Currently have an alcohol/substance abuse problem or have had a relapse within one year to screening visit
- Have an abscess or infection at the time of surgery
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03805698
Start Date
January 3 2019
End Date
February 6 2021
Last Update
October 6 2022
Active Locations (1)
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1
Cedars-Sinai Department of Hand Surgery
Los Angeles, California, United States, 90048