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Platelet-rich Plasma
PRP Injections for Shoulder Osteoarthritis
Phase 4
Recruiting
Research Sponsored by Hospital for Special Surgery, New York
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 up to 12 months post-injection
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will compare treatments for glenohumeral OA: physical activity, injections, medications, low-dose PRP, high-dose PRP and saline injections. Results will determine which is most effective.
Who is the study for?
This trial is for adults aged 18-100 with shoulder osteoarthritis who've had pain for at least 3 months despite trying physical therapy and other conservative treatments. Participants need an email or network access, an MRI of the affected joint, and a pain score of at least 5/10 due to the condition. They must have experienced temporary relief from a diagnostic joint injection. Those on NSAIDs can't join, nor can those involved in workers' comp claims, recent recipients of certain injections or treatments, or individuals with uncontrolled illnesses.
What is being tested?
The study tests single injections of two different doses of PRP (Platelet-Rich Plasma) against saline to see which is more effective for shoulder osteoarthritis. Previous studies used low-dose PRP; this one includes both low-dose (~3X concentration) and high-dose PRP to compare outcomes.
What are the potential side effects?
PRP may cause side effects such as pain at the injection site, tissue damage, infection risk increase due to needle insertion into the joint space, allergic reactions or increased inflammation within the treated area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Secondary study objectives
Average numerical rating scale (NRS) pain score
Medication use
PROMIS Sleep Disturbance
+3 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-dose PRPExperimental Treatment1 Intervention
Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).
Group II: High-dose PRPExperimental Treatment1 Intervention
Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).
Group III: Saline controlPlacebo Group1 Intervention
Patients will receive a single injection of 6 ml saline into the glenohumeral joint.
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 100 years old.I have had pain for over 3 months despite trying treatments like physical therapy.I have ongoing cervical health issues that aren't managed.I felt better temporarily after getting a joint injection for diagnosis.I have had a platelet-rich plasma injection before.I have recent fractures or severe deformities.My shoulder pain from arthritis or cartilage loss averages 5/10 or more.I have not had a steroid injection in the last 3 months.I do not have any uncontrolled illnesses like diabetes or autoimmune diseases.I have taken Plavix before.I can stop taking NSAIDs 2 weeks before and 1 month after an injection.
Research Study Groups:
This trial has the following groups:- Group 1: Low-dose PRP
- Group 2: High-dose PRP
- Group 3: Saline control
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT05675527 — Phase 4
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