NCT03830775

Brief Summary

Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. This process has not yet been proven for non-operative management of the Triangular FibroCartilage Complex (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks to determine the efficacy of PRP for TFCC injuries.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

February 1, 2019

Last Update Submit

September 23, 2025

Conditions

Wrist InjuriesPRP

Keywords

TFCCPRP

Outcome Measures

Primary Outcomes (5)

  • Disability of the Army Shoulder Hand (DASH)

    SCALE: 0-100 (0 being a good result and 100 being complete disability)

    Pre-injection

  • Disability of the Army Shoulder Hand (DASH)

    SCALE: 0-100 (0 being a good result and 100 being complete disability)

    2 weeks post injection

  • Disability of the Army Shoulder Hand (DASH)

    SCALE: 0-100 (0 being a good result and 100 being complete disability)

    3 months post injection

  • Disability of the Army Shoulder Hand (DASH)

    SCALE: 0-100 (0 being a good result and 100 being complete disability)

    6 months post injection

  • Disability of the Army Shoulder Hand (DASH)

    SCALE: 0-100 (0 being a good result and 100 being complete disability)

    12 months post injection

Secondary Outcomes (4)

  • Michigan Hand Outcome Questionnaire (MHOQ

    Pre-injection, 2 weeks, 3 months

  • Mayo Wrist Score (Mayo)

    Pre-injection, 2 weeks, 3 months, 6 months, 12 months

  • Pain Anxiety Symptom Scale (PASS)

    Pre-injection, 2 weeks, 3 months

  • Single Assessment Numerical Evaluation (SANE)

    Pre-injection, 2 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Experimental - PRP injection

EXPERIMENTAL

2cc of PRP is injected into the ulnocarpal joint

Procedure: Platelet-rich plasma (PRP)

control - Saline injection

PLACEBO COMPARATOR

2cc of 0.9% sterile saline is injected into the ulnocarpal joint

Procedure: Platelet-rich plasma (PRP)

Interventions

Platelet-rich plasma (PRP)PROCEDURE

PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic. All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline)

Experimental - PRP injectioncontrol - Saline injection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients consenting for wrist injection, who additionally consent to participate in this study.
  • MRI which indicates a TFCC tear or Scapho-lunate ligament tear (SL)

You may not qualify if:

  • Patients who do not choose to participate in the study or who do not wish to have an injection
  • Patients who want an injection - but do not want to be randomized.
  • Patients who do not complete one of the follow up documentations.
  • Patients who would like to know their injection (unblinded) may be informed but the investigators will still attempt to collect data as per protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lola Norton

El Paso, Texas, 79903, United States

Location

Related Publications (7)

  • Padilla S, Orive G, Sanchez M, Anitua E, Hsu WK. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2014 Aug;22(8):469-70. doi: 10.5435/JAAOS-22-08-469. No abstract available.

    PMID: 25063744BACKGROUND

  • Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.

    PMID: 24292930BACKGROUND

  • Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.

    PMID: 28012636BACKGROUND

  • Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.

    PMID: 21422467BACKGROUND

  • Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.

    PMID: 20448192BACKGROUND

  • Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. doi: 10.1016/s0363-5023(81)80170-0.

    PMID: 7229292BACKGROUND

  • Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.

    PMID: 18261664BACKGROUND

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Officials

  • John C Dunn

    WBAMC Staff Hand Surgeon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Human Protection Director

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 5, 2019

Study Start

October 2, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)