Suspended

TFCCA Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries

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What is being tested

Platelet-rich plasma (PRP)

Procedure
Who is being recruted

Arm Injuries

+ Wounds and Injuries

+ Wrist Injuries

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2020
See protocol details

Summary

Principal SponsorEdna Rath
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 2, 2020

Actual date on which the first participant was enrolled.

Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common (Hsu) 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. (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10 prospective randomized controlled trials proving the effectiveness of PRP for knee osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca). Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty) PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann, Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to dissipate compressive forces. Tears within this soft tissue structure are painful and heal slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the mainstays of treatment. However, PRP has not been studied as a treatment modality. The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a TFCC tear. The null hypothesis is that there is no difference between injection into the wrist of PRP and saline (placebo). The investigators hypothesize that PRP will reduce pain as compared to placebo.

Official TitleA Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries
NCT03830775
Principal SponsorEdna Rath
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arm InjuriesWounds and InjuriesWrist Injuries

Criteria

2 inclusion criteria required to participate
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)

4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
2cc of PRP is injected into the ulnocarpal joint

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Lola Norton

El Paso, United StatesOpen Lola Norton in Google Maps
SuspendedOne Study Center