PRP for Glenohumeral Osteoarthritis

Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Osteoarthritis
• Intervention / Treatment: Biological: Low-dose PRP; Biological: High-dose PRP; Other: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jonathan Kirschner, MD; Phone Number: 646-714-6327; Email: kirschnerj@hss.edu
• Study Contact Backup: Name: Jennifer Cheng; Phone Number: 646-714-6870; Email: chengj@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Jonathan Kirschner, MD; Email: kirschnerj@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Biological: Low-dose PRP; Injection
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).	Biological: High-dose PRP; Injection
Placebo Comparator: Saline control; Patients will receive a single injection of 6 ml saline into the glenohumeral joint.	Other: Saline; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average numerical rating scale (NRS) pain score	Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.	Up to 12 months post-injection
Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure	The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.	Up to 12 months post-injection
PROMIS-Upper Extremity computer adaptive test (CAT)	The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.	Up to 12 months post-injection
Medication use	Patients will be asked if they are using any of the following medications: non-steroidal anti-inflammatory drugs, opioids, selective serotonin reuptake inhibitors, or neuropathic medications.	Up to 12 months post-injection
PROMIS Sleep Disturbance	The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).	Up to 12 months post-injection
Patient satisfaction	Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".	Up to 12 months post-injection

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2022-0720

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No