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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wrist Injuries, PRP

Intervention / Treatment
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* Procedure: Platelet-rich plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) Exclusion criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TFCC, PRP