Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears

Cedars-Sinai Medical Center

Status: Terminated

Conditions: Arthroscopic Surgery; Triangular Fibrocartilage Complex Injury

Treatments: Device: Platelet-rich Plasma (PRP); Other: Standard Arthroscopic Debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT03805698

Pro00053449

Details and patient eligibility

About

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 (TFCC) tears to subjects treated with arthroscopic debridement alone.

Full 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 subjects) versus no treatment with PRP (24 subjects). Outcome measures will include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion, functional status) and Patient-rated Wrist Evaluation (PRWE) scores.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Platelet-rich Plasma (PRP) group

Experimental group

Description:

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

Treatment:

Device: Platelet-rich Plasma (PRP)

Standard Treatment group

Active Comparator group

Description:

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:

Other: Standard Arthroscopic Debridement