Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06422390

PRP for Rotator Cuff Tears

Platelet - Rich Plasma Injections for Rotator Cuff Tears

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Scripps Clinic · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options. Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling. Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlatelet - Rich PlasmaPlatelet - Rich Plasma is a biologic injection created from the patient's own blood. 52cc of the patient's blood is drawn then mixed with 8cc of anticoagulant. The blood mixture will be spun down using a centrifuge that can separate the platelet-rich plasma from the other contents in the blood. Once the centrifuge process is complete the Platelet - Rich Plasma is ready to be used.

Timeline

Start date
2025-01-05
Primary completion
2025-01-06
Completion
2025-01-06
First posted
2024-05-21
Last updated
2025-01-08

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06422390. Inclusion in this directory is not an endorsement.