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

NCT03805698 | Terminated Results FDA Device

• 1 other identifier: Pro00053449
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroscopic Surgery; Triangular Fibrocartilage Complex Injury

Keywords

Platelet-rich Plasma

Outcome Measures

Primary Outcomes (5)

• Patient-rated Wrist Evaluation (PRWE) Scores

  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.

  change from pre to post-op

• Modified Mayo Wrist Score - Grip Strength Score

  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.

  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 - Pain Score

  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

  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 - Range of Motion Score

  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.

  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

  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

  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.

Study Arms (2)

Platelet-rich Plasma (PRP) group

EXPERIMENTAL

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

Device: Platelet-rich Plasma (PRP)

Standard Treatment group

ACTIVE COMPARATOR

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

Other: Standard Arthroscopic Debridement

Interventions

Platelet-rich Plasma (PRP) 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.

Also known as: PRP group, Treatment group

Platelet-rich Plasma (PRP) group

Standard Arthroscopic Debridement OTHER

Standard arthroscopic debridement. No PRP injection.

Also known as: Standard Treatment, Control group

Standard Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Department of Hand Surgery

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: David Kulber, MD, PI
• Organization: Cedars-Sinai Medical Center

david.kulber@cshs.org

3104235900

Study Officials

• David Kulber, MD

  Cedars-Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated with PRP (24 subjects) versus no treatment with Platelet-rich plasma (PRP) (24 subjects).

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 16, 2019
• Study Start: January 3, 2019
• Primary Completion: February 6, 2021
• Study Completion: February 6, 2021
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-09

Locations

US (1)