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

Not Applicable

Terminated

Conditions: Triangular Fibrocartilage Complex Injury
Arthroscopic Surgery

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

Registration Number: NCT03805698

Lead Sponsor: Cedars-Sinai Medical Center

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

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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment group	Standard Arthroscopic Debridement	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
Platelet-rich Plasma (PRP) group	Platelet-rich Plasma (PRP)	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

Primary Outcome Measures

Name	Time	Method
Modified Mayo Wrist Score - Pain Score	Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1	Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale
Modified Mayo Wrist Score - Range of Motion Score	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.	Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.
Modified Mayo Wrist Score - Grip Strength Score	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.	Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement. Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.
Modified Mayo Wrist Score - Functional Status Score	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.	Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment
Patient-rated Wrist Evaluation (PRWE) Scores	change from pre to post-op	The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150. Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.