Clinical trial NCT03805698: Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
Official title: Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroscopic Surgery
Triangular Fibrocartilage Complex Injury
Keywords: Platelet-rich Plasma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-rated Wrist Evaluation (PRWE) Scores
timeFrame: change from pre to post-op
measure: Modified Mayo Wrist Score - Grip Strength Score
timeFrame: 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.
measure: Modified Mayo Wrist Score - Pain Score
timeFrame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1
measure: Modified Mayo Wrist Score - Range of Motion Score
timeFrame: 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.
measure: Modified Mayo Wrist Score - Functional Status Score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Department of Hand Surgery
state: California
Study officials:
affiliation: Cedars-Sinai
name: David Kulber, MD
role: PRINCIPAL_INVESTIGATOR
References: