PRP for Rotator Cuff Tears

Withdrawn

• Conditions: Rotator Cuff Tears
• Interventions: Biological: Platelet - Rich Plasma

• Registration Number: NCT06422390
• Lead Sponsor: Scripps Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Status Verified: 2025-01
• Study Start: 2025-01-05
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-06
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRP Injection	Platelet - Rich Plasma	Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.

Primary Outcome Measures

Name	Time	Method
Improvement of pain and function	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 Outcome Measures

Name	Time	Method
Improvement in VAS scores and patient satisfaction	June 2024 to June 2025	Secondary Outcome: Improvement in visual analog scale (VAS) pain scores at 6 weeks, 12 weeks, 6 months, and 1 year. Additional secondary outcomes: Patients' perception of overall improvement with their shoulder, patient satisfaction with outcome, tendon healing assessed by ultrasound evaluation, progression to surgical management or other intervention such as corticosteroid injections (CSI), and association between volume of Plasma Rich Platelet (PRP) and outcomes.; The visual analog scale (VAS): No pain (0) - mild pain (1-2) - moderate pain (3-4) - Severe Pain (5-6) - Very sever pain (7-8) - Worst possible pain (9-10); The higher the number the worst the outcome is. The lower the number the better the outcome is.

Trial Locations

Locations (1)

Scripps Clinic - Torrey Pines; 🇺🇸 La Jolla, California, United States