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

The University of Alabama at Birmingham

Status: Terminated

Conditions: Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff

Treatments: Procedure: PRP injection into PTRCT; Drug: Subacromial steroid bursal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02246530

F131231006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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11 participants in 2 patient groups

PRP injection into PTRCT

Active Comparator group

Description:

Treatment - PRP injection

Treatment:

Procedure: PRP injection into PTRCT

Subacromial steroid bursal injection

Active Comparator group

Description:

Current standard of care for treatment of resistant partial thickness rotator cuff tears

Treatment:

Drug: Subacromial steroid bursal injection