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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 19 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
PRP injection into PTRCT 		Treatment - PRP injection
  • 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.
    Other names:
    • Biologics
Active Comparator
Subacromial steroid bursal injection 		Current standard of care for treatment of resistant partial thickness rotator cuff tears
  • 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
    Other names:
    • Procedure

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.