Trial record 32 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Lacerations"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02246530
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : April 19, 2017
Information provided by (Responsible Party):
Rachel Geffen, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Partial Tear of Rotator Cuff Tendinopathy of Rotator Cuff Procedure: PRP injection into PTRCT Drug: Subacromial steroid bursal injection

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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 Name: 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 Name: Procedure

Primary Outcome Measures :
  1. Diagnostic Ultrasound [ Time Frame: 6 months post procedure ]
    Comparing baseline diagnostic ultrasound for structural changes

Secondary Outcome Measures :
  1. Shoulder Pain and Disability Index [ Time Frame: Week 3, 6 and 6 months post procedure ]
    Comparing questionnaire for changes in pain and/or disability

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02246530

Contact: Alex Cotter 205-934-3335
Contact: Sherricka Embery 205-934-3283

United States, Alabama
UAB Highlands Recruiting
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Alex Cotter, MD University of Alabama at Birmingham

Responsible Party: Rachel Geffen, Principal Investigator, University of Alabama at Birmingham Identifier: NCT02246530     History of Changes
Other Study ID Numbers: F131231006
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases