Suspended

Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Thickness Rotator Cuff Tears. A Randomized, Prospective, Double Blinded Trial.

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What is being tested

Platelet Rich Plasma (PRP)

+ Corticosteroid

BiologicalDrug
Who is being recruted

Shoulder Injuries+2

+ Rupture

+ Tendon Injuries

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: April 17, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: April 17, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Shoulder InjuriesRuptureTendon InjuriesWounds and InjuriesRotator Cuff Injuries

Criteria

2 inclusion criteria required to participate
Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound

Shoulder pain for at least two weeks

7 exclusion criteria prevent from participating
Cancer

Current treatment with anticoagulation medication

Full thickness rotator cuff tear

Pregnancy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects in this group will receive 2 injections with PRP. Each injection separated by two weeks.

Group II

Active Comparator
Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of North Carolina Department of Orthopaedics

Chapel Hill, United StatesOpen University of North Carolina Department of Orthopaedics in Google Maps
SuspendedOne Study Center