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

NCT ID: NCT03805698

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2021-02-06

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.

Conditions

Arthroscopic Surgery; Triangular Fibrocartilage Complex Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Platelet-rich Plasma (PRP) group

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 Type: EXPERIMENTAL

Platelet-rich Plasma (PRP)

Intervention Type: DEVICE

The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.

Standard Treatment group

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

Group Type: ACTIVE_COMPARATOR

Standard Arthroscopic Debridement

Intervention Type: OTHER

Standard arthroscopic debridement. No PRP injection.

Interventions

Platelet-rich Plasma (PRP)

The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.

Intervention Type: DEVICE

Standard Arthroscopic Debridement

Standard arthroscopic debridement. No PRP injection.

Intervention Type: OTHER

Other Intervention Names

PRP group; Treatment group; Standard Treatment; Control group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Kulber, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kulber, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai

Locations

Cedars-Sinai Department of Hand Surgery

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00053449

Identifier Type: -

Identifier Source: org_study_id