PRP vs Corticosteroid Injections for Shoulder Osteoarthritis

(PRP Trial)

Overseen By Kelly Kilcoyne, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Walter Reed National Military Medical Center

Must not be taking: Narcotics

Disqualifiers: Diabetes, Inflammatory arthropathies, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates LP-PRP injections for young active duty and civilian patients with shoulder osteoarthritis. The treatment uses concentrated platelets from the patient's own blood to promote healing and reduce inflammation, aiming to improve pain and function without surgery. This method has shown potential in treating various inflammatory and degenerative conditions by modulating the inflammatory environment and promoting tissue repair.

Eligibility Criteria

This trial is for men and women aged 18-70 with shoulder pain from mild to moderate osteoarthritis that hasn't improved with standard treatments. They must not have had recent injections or surgery in the affected shoulder, be pregnant, or have conditions like diabetes, fibromyalgia, chronic fatigue syndrome, or a history of bad reactions to PRP or corticosteroids.

Inclusion Criteria

Willing and able to give voluntary informed consent to participate in this investigation

My shoulder arthritis hasn't improved with standard treatments.

I have shoulder pain from mild to moderate arthritis.

Exclusion Criteria

I do not have any serious health conditions that could affect my participation.

Patients with planned deployment or separation from the military within 12 months

I had shoulder surgery within the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either corticosteroid or platelet-rich plasma injections

6 weeks

1 visit (in-person) for injection, follow-up visits at 3 weeks and 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up assessments at 3 months, 6 months, 12 months, and 24 months

Treatment Details

Interventions

• Corticosteroid Injection
• Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure
• Platelet Rich Plasma Injection

Trial Overview The study compares three non-surgical treatments for shoulder osteoarthritis: Platelet Rich Plasma (PRP) injection, Corticosteroid injection, and delayed PRP after Corticosteroid failure. It aims to find out which treatment might best help young active people avoid surgery by improving tissue healing.

Participant Groups

Group I: Platelet Rich Plasma Injection Group Experimental Treatment 1 Intervention

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Group II: Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure Experimental Treatment 1 Intervention

If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection.

Group III: Corticosteroid Injection Group Active Control 1 Intervention

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Corticosteroid Injection is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in United States as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Approved in Canada as Corticosteroid injection for:

• Acromioclavicular joint pain
• Shoulder impingement syndrome
• Rotator cuff disease
• Adhesive capsulitis
• Glenohumeral osteoarthritis

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+