Trial Outcomes & Findings for Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears (NCT NCT03805698)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

change from pre to post-op

Results posted on

2022-10-06

Participant Flow

medical clinic from 07/22/19-02/02/2020

Participant milestones

Participant milestones
Measure	Platelet-rich Plasma (PRP) Group Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects). Intervention: use of Cascade device; Autologous Fibrin \& Platelet System; once processed, the PRP is injected into the debrided wrist 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.	Standard Treatment Group Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects). Intervention: No PRP injection into debrided wrist Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.
Overall Study STARTED	10	0
Overall Study COMPLETED	10	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platelet-rich Plasma (PRP) Group n=10 Participants Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects). Intervention: use of Cascade device; Autologous Fibrin \& Platelet System; once processed, the PRP is injected into the debrided wrist 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.	Standard Treatment Group Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects). Intervention: No PRP injection into debrided wrist Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	—	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=10 Participants	—	9 Participants n=10 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants	—	1 Participants n=10 Participants
Age, Continuous	54.9 years n=10 Participants	—	54.9 years n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants	—	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	—	3 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 Participants n=10 Participants	—	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: change from pre to post-op

Population: The intervention was incomplete due to COVID and questionnaires were not obtained.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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.

Population: The Grip strength score was not obtained.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: Measurement was not obtained for any subject.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

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.

Population: The wrist score was not obtained for any patient in the study.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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.

Population: Wrist score was not obtained for any subject.

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

Outcome measures

Outcome data not reported

Adverse Events

Platelet-rich Plasma (PRP) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Kulber, MD, PI

Cedars-Sinai Medical Center

Phone: 3104235900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place