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Clinical Trials/NCT06422390
NCT06422390
Withdrawn
Not Applicable

Platelet - Rich Plasma Injections for Rotator Cuff Tears

Scripps Clinic1 site in 1 country76 target enrollmentJanuary 5, 2025

Overview

Phase
Not Applicable
Intervention
Platelet - Rich Plasma
Conditions
Rotator Cuff Tears
Sponsor
Scripps Clinic
Enrollment
76
Locations
1
Primary Endpoint
Improvement of pain and function
Status
Withdrawn
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 5, 2025
End Date
January 6, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laika Nur

Clinical Assistant Professor of Orthopedic Surgery - Division of Sports Medicine

Scripps Clinic

Eligibility Criteria

Inclusion Criteria

  • Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI
  • Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with ultrasound.

Exclusion Criteria

  • Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy)
  • Patient with previous surgical interventions on the same rotator cuff.
  • Patients on aspirin who cannot discontinue medication 1 week prior and 6 weeks after the procedure.
  • Patients who decline to discontinue anti-inflammatory medications or supplements for 1 week prior and 6 weeks after the procedure.
  • Any procedure that utilized less than 2-3 cc of PRP
  • Patients that require blood to be drawn twice on the same day.

Arms & Interventions

PRP Injection

Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.

Intervention: Platelet - Rich Plasma

Outcomes

Primary Outcomes

Improvement of pain and function

Time Frame: June 2024 to June 2025

Primary outcome: Improvement in patients' subjective pain and function as measured by the American Shoulder and Elbow Surgeons (ASES) score at 6 weeks, 12 weeks, 6 months, and 1 year. Minimum value: No difficulty with normal function of the shoulder and there is no pain. Maximum value: Extreme difficulty with normal function and the pain is as bad as it can be. Pain scale is 0 to 10 with the meaning that scale starts from 0 (no pain) to 10 (pain as bad as it can be).

Secondary Outcomes

  • Improvement in VAS scores and patient satisfaction(June 2024 to June 2025)

Study Sites (1)

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