Recruiting

PRP

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT05675527

Conditions

Shoulder Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low-dose PRP

High-dose PRP

Saline

Study Details

Brief summary:

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.

Conditions

Shoulder Osteoarthritis

Study ID

NCT05675527

Start date

May 2, 2023

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-100 years old
  • Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss
  • At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy
  • MRI of the affected joint
  • Transient relief of symptoms after a diagnostic intra-articular injection into the joint
  • Email address or network access

Exclusion Criteria:

  • Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection
  • Prior platelet-rich plasma injection
  • Steroid injection within 3 months of the initial injection
  • Hyaluronic acid within 6 months of the initial injection
  • Involved in workers' compensation or active litigation involving the affected joint
  • History of Plavix use
  • Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)
  • Presence of acute fractures or gross mechanical deformities
  • Concurrent "uncontrolled" cervical disorders

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Low-dose PRP

Injection

High-dose PRP

Injection

Saline

Injection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jonathan Kirschner, MD

646-714-6327kirschnerj@hss.edu

Jennifer Cheng

646-714-6870chengj@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Jonathan Kirschner, MD

kirschnerj@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Oct 6, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2025-10-06.