PRP for Glenohumeral Osteoarthritis

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05675527
Phase
PHASE4
Status
Recruiting
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Conditions

  • Shoulder Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose PRP — BIOLOGICAL
    Injection
  • High-dose PRP — BIOLOGICAL
    Injection
  • Saline — OTHER
    Injection

Study Details

The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (\~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.

Key Dates

Start date
May 2, 2023
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose PRP
    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).
  • Experimental: High-dose PRP
    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).
  • Placebo Comparator: Saline control
    Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Primary Outcome Measure

American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: 3 months post-injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Jonathan Kirschner, MD
[email protected]

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