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Treatment Group for Rotator Cuff Tears

N/A

Waitlist Available

Led By Chadwick Prodromos, MD

Research Sponsored by The Foundation for Orthopaedics and Regenerative Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 24 months

Awards & highlights

No Placebo-Only Group

Summary

The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Eligible Conditions

Rotator Cuff Tears
Rotator Cuff Tendinitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)

Secondary study objectives

Global Improvement

Visual Analog Scale (VAS) for pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Dual injections of PRP - 4 ml injected into each location. The first injection was into the supraspinatus tendon insertion critical zone and bursal area with the patient seated. The second injection was performed with the patient prone into the glenohumeral intra-articular space under the supraspinatus tendon at, or just proximal to, the superior equator of the humeral head.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma (PRP)

2015

Completed Phase 4

~330

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