Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma

Overview

The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2021

Detailed Description

Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.

Interventions

  • Procedure: PRP injection into PTRCT
    • Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury. PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
  • Drug: Subacromial steroid bursal injection
    • Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient’s subacromial bursa via needle guidance of ultrasound

Arms, Groups and Cohorts

  • Active Comparator: PRP injection into PTRCT
    • Treatment – PRP injection
  • Active Comparator: Subacromial steroid bursal injection
    • Current standard of care for treatment of resistant partial thickness rotator cuff tears

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic Ultrasound
    • Time Frame: 6 months post procedure
    • Comparing baseline diagnostic ultrasound for structural changes

Secondary Measures

  • Shoulder Pain and Disability Index
    • Time Frame: Week 3, 6 and 6 months post procedure
    • Comparing questionnaire for changes in pain and/or disability

Participating in This Clinical Trial

Inclusion Criteria

1. subjects between ages 19 to 75, both male and female

2. radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears

3. Failed a trial of physical therapy of at least 4 weeks

Exclusion Criteria

1. Full thickness tears (well documented need for surgical correction)

2. sensory or neurologic complaint affecting the shoulder of interest

3. Coagulation disorder, platelet disorder

4. Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study

5. Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy

6. Prior surgery to either cervical spine or shoulder

7. Active military

8. Injury part of worker compensation claim

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ryan Dill MD, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Ryan Dill, MD, Principal Investigator, University of Alabama at Birmingham
  • Overall Contact(s)
    • Ryan Dill, MD, 205-934-6934, rdill@uab.edu

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