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

NCT ID: NCT02246530

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2021-03-31

Brief Summary

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.

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.

Conditions

Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRP injection into PTRCT

Treatment - PRP injection

Group Type: ACTIVE_COMPARATOR

PRP injection into PTRCT

Intervention Type: PROCEDURE

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.

Subacromial steroid bursal injection

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

Group Type: ACTIVE_COMPARATOR

Subacromial steroid bursal injection

Intervention Type: DRUG

Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

Biologics; Procedure

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Breanna Willeford

Resident Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Breanna Willeford, DO

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Highlands

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

F131231006

Identifier Type: -

Identifier Source: org_study_id