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

PRP Clinical Trial

— TFCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830775
• Other study ID #: williamBAMC
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: William Beaumont Army Medical Center
• Contact: Michael Polmear
• Phone: (303) 910-8665
• Email: michael.polmear[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• PRP
• Wounds and Injuries
• Wrist Injuries

Intervention

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 ß (TGFß), 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)

Locations

Country	Name	City	State
United States	Lola Norton	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Revi — View Citation

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) — View Citation

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: 10.1 — View Citation

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. Revie — View Citation

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. — View Citation

Palmer AK, Werner FW. The triangular fibrocartilage complex of the wrist--anatomy and function. J Hand Surg Am. 1981 Mar;6(2):153-62. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of the Army Shoulder Hand (DASH)	SCALE: 0-100 (0 being a good result and 100 being complete disability)	Pre-injection
Primary	Disability of the Army Shoulder Hand (DASH)	SCALE: 0-100 (0 being a good result and 100 being complete disability)	2 weeks post injection
Primary	Disability of the Army Shoulder Hand (DASH)	SCALE: 0-100 (0 being a good result and 100 being complete disability)	3 months post injection
Primary	Disability of the Army Shoulder Hand (DASH)	SCALE: 0-100 (0 being a good result and 100 being complete disability)	6 months post injection
Primary	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	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
Secondary	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
Secondary	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
Secondary	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