PRP for Glenohumeral Osteoarthritis

Phase 4RecruitingNCT05675527

Hospital for Special Surgery, New York135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

135

Conditions

Shoulder Osteoarthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 months post-injection

Secondary Outcomes

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.