RecruitingPhase 4NCT05675527

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

Sponsor

Hospital for Special Surgery, New York

Enrollment

135 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Shoulder Osteoarthritis

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria6

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 Criteria9

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

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