PRP for Glenohumeral Osteoarthritis

NCT05675527 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2022-0720
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.

  3 months post-injection

Secondary Outcomes (6)

• Average numerical rating scale (NRS) pain score

  Up to 12 months post-injection

• Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure

  Up to 12 months post-injection

• PROMIS-Upper Extremity computer adaptive test (CAT)

  Up to 12 months post-injection

• Medication use

  Up to 12 months post-injection

• PROMIS Sleep Disturbance

  Up to 12 months post-injection

Study Arms (3)

Low-dose PRP

EXPERIMENTAL

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).

Biological: Low-dose PRP

High-dose PRP

EXPERIMENTAL

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).

Biological: High-dose PRP

Saline control

PLACEBO COMPARATOR

Patients will receive a single injection of 6 ml saline into the glenohumeral joint.

Other: Saline

Interventions

Low-dose PRP BIOLOGICAL

Injection

Low-dose PRP

High-dose PRP BIOLOGICAL

Injection

High-dose PRP

Saline OTHER

Injection

Saline control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Jonathan Kirschner, MD

CONTACT

646-714-6327; kirschnerj@hss.edu

Jennifer Cheng

CONTACT

646-714-6870; chengj@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 9, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (1)