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

NCT02246530 | Terminated Results

• 1 other identifier: F131231006
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• Diagnostic Ultrasound

  Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.

  6 months post procedure

Secondary Outcomes (3)

• Shoulder Pain and Disability Index

  Week 3 post procedure SPADI Scores for the control and treatment groups.

• Shoulder Pain and Disability Index

  Week 6 post procedure SPADI Scores for the treatment and control groups.

• Shoulder Pain and Disability Index

  6 months post procedure SPADI scores for the treatment and control groups.

Study Arms (2)

PRP injection into PTRCT

ACTIVE COMPARATOR

Treatment - PRP injection

Procedure: PRP injection into PTRCT

Subacromial steroid bursal injection

ACTIVE COMPARATOR

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

Drug: Subacromial steroid bursal injection

Interventions

PRP injection into PTRCT 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.

Also known as: Biologics

PRP injection into PTRCT

Subacromial steroid bursal injection DRUG

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

Also known as: Procedure

Subacromial steroid bursal injection

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects between ages 19 to 75, both male and female
• 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
• Failed a trial of physical therapy of at least 4 weeks

You may not qualify if:

• Full thickness tears (well documented need for surgical correction)
• sensory or neurologic complaint affecting the shoulder of interest
• Coagulation disorder, platelet disorder
• Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study
• Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy
• Prior surgery to either cervical spine or shoulder
• Active military
• Injury part of worker compensation claim

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highlands

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Biological Products; Methods

Intervention Hierarchy (Ancestors)

Complex Mixtures; Investigative Techniques

Results Point of Contact

• Title: Dr. Breanna Willeford, DO
• Organization: University of Alabama at Birmingham

breannawilleford@uabmc.edu

205-934-4131

Study Officials

• Breanna Willeford, DO

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 22, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-05

Locations

US (1)