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
| Type | Name | Description |
|---|---|---|
| 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. |
| 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 |
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.