A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries (TFCC)

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.

Study Overview

• Status: Recruiting
• Conditions: Wrist Injuries; PRP
• Intervention / Treatment: Procedure: Platelet-rich plasma (PRP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Polmear; Phone Number: (303) 910-8665; Email: michael.polmear@gmail.com

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79903
      • Recruiting
      • Lola Norton
      • Contact: Larissa Schmersal; Phone Number: 915-742-9502; Email: larissa.a.schmersal.civ@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

Exclusion criteria:

1. Patients who do not choose to participate in the study or who do not wish to have an injection
2. Patients who want an injection - but do not want to be randomized.
3. Patients who do not complete one of the follow up documentations.
4. 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental - PRP injection; 2cc of PRP is injected into the ulnocarpal joint	Procedure: Platelet-rich plasma (PRP); 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)
Placebo Comparator: control - Saline injection; 2cc of 0.9% sterile saline is injected into the ulnocarpal joint	Procedure: Platelet-rich plasma (PRP); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Outcome Questionnaire (MHOQ	SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)	Pre-injection, 2 weeks, 3 months
Mayo Wrist Score (Mayo)	SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)	Pre-injection, 2 weeks, 3 months, 6 months, 12 months
Pain Anxiety Symptom Scale (PASS)	SCALE: 0-100 (100 meaning a patient has a high level of anxiety, pain, apprehension; while a lower scale indicates a patient has no concerns or anxiety about pain. The average is about 38 and the standard deviation is 20)	Pre-injection, 2 weeks, 3 months
Single Assessment Numerical Evaluation (SANE)	SCALE: 0-100 (with 100 being a great result and 0 being considerable pain and dysfunction)	Pre-injection, 2 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: William Beaumont Army Medical Center
• Investigators: Principal Investigator: John C Dunn, WBAMC Staff Hand Surgeon

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 1, 2019
• First Submitted That Met QC Criteria: February 2, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: PRP; TFCC
• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Wrist Injuries
• Other Study ID Numbers: williamBAMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No