Clinical Trials Directory

Trials / Terminated

TerminatedNCT02246530

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
19 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREPRP injection into PTRCTDay 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.
DRUGSubacromial steroid bursal injectionCombination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound

Timeline

Start date
2014-07-01
Primary completion
2021-01-01
Completion
2021-03-01
First posted
2014-09-22
Last updated
2022-05-16
Results posted
2022-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02246530. Inclusion in this directory is not an endorsement.