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

Arthroscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03805698
• Other study ID #: Pro00053449
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: February 6, 2021

Study information

• Verified date: September 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroscopic Surgery
• Triangular Fibrocartilage Complex Injury

Intervention

Device:
• 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.

Other:
• Standard Arthroscopic Debridement
Standard arthroscopic debridement. No PRP injection.

Locations

Country	Name	City	State
United States	Cedars-Sinai Department of Hand Surgery	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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.
Primary	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.