Arthroscopic SurgeryNCT03805698

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

A study testing Platelet-rich Plasma (PRP) and Standard Arthroscopic Debridement in people with Arthroscopic Surgery and Triangular Fibrocartilage Complex Injury, run by Cedars-Sinai Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroscopic Surgery, Triangular Fibrocartilage Complex Injury
What is being tested?: Platelet-rich Plasma (PRP) and Standard Arthroscopic Debridement
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2019to 6 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Department of Hand Surgery
Los Angeles, California, 90048

Other trials in United States

About this study

Read the 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
Being tested: Platelet-rich Plasma (PRP), Standard Arthroscopic Debridement
Keywords: Platelet-rich Plasma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Platelet-rich Plasma (PRP)Device
Also called PRP group, Treatment group
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 Arthroscopic DebridementOther
Also called Standard Treatment, Control group
Standard arthroscopic debridement. No PRP injection.

Study groups in NCT03805698
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Standard Arthroscopic Debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 20196 Feb 2021

First posted16 Jan 2019
Study start3 Jan 2019
Primary completion6 Feb 2021
Study completion6 Feb 2021

Why it stopped: COVID stopped surgeries

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroscopic SurgeryStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03805698
Sponsor's protocol ID: Pro00053449
Status last verified: Sep 2022
First submitted: 7 Jan 2019
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears
ClinicalTrials.gov ID: NCT03805698
Acronym / sponsor ID: Pro00053449
Conditions: Arthroscopic Surgery, Triangular Fibrocartilage Complex Injury
Keywords: Platelet-rich Plasma
Study type: Interventional
Recruitment status: TerminatedReason stopped: COVID stopped surgeries
Enrolment: 10 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: 3 Jan 2019 (actual)
Primary completion: 6 Feb 2021 (actual)
Study completion: 6 Feb 2021 (actual)
First posted: 16 Jan 2019 (actual)
Results: Posted 6 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Platelet-rich Plasma (PRP) group	Experimental	Device: Platelet-rich Plasma (PRP)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
Standard Treatment group	Active comparator	Other: Standard Arthroscopic DebridementTwenty-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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Platelet-rich Plasma (PRP)Also: PRP group, Treatment groupThe 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.	Device	Platelet-rich Plasma (PRP) group
Standard Arthroscopic DebridementAlso: Standard Treatment, Control groupStandard arthroscopic debridement. No PRP injection.	Other	Standard Treatment group

Primary outcome

Patient-rated Wrist Evaluation (PRWE) Scores
Time frame: change from pre to post-op
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.
Modified Mayo Wrist Score - Grip Strength Score
Time frame: 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 - 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.
Modified Mayo Wrist Score - Pain Score
Time frame: 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 - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale
Modified Mayo Wrist Score - Range of Motion Score
Time frame: 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 - 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.
Modified Mayo Wrist Score - Functional Status Score
Time frame: 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: 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

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Platelet-rich Plasma (PRP) Group	10	10
Standard Treatment Group	0	0

Primary outcome: Patient-rated Wrist Evaluation (PRWE) Scores

Time frame: change from pre to post-op

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

Primary outcome: Modified Mayo Wrist Score - Grip Strength Score

Time frame: 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 analysed: The Grip strength score was not obtained.

Primary outcome: Modified Mayo Wrist Score - Pain Score

Time frame: 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 analysed: Measurement was not obtained for any subject.

Primary outcome: Modified Mayo Wrist Score - Range of Motion Score

Time frame: 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 analysed: The wrist score was not obtained for any patient in the study.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Platelet-rich Plasma (PRP) Group	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Standard Treatment Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Kulber, MD principal investigator

Cedars-Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-rated Wrist Evaluation (PRWE) Scores (time frame: change from pre to post-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.