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NCT05675527 | RECRUITING | Shoulder Osteoarthritis

PRP for Glenohumeral Osteoarthritis
Sponsor:

Hospital for Special Surgery, New York

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.

Condition or disease

Shoulder Osteoarthritis

Intervention/treatment

Low-dose PRP

High-dose PRP

Saline

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 135 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-05-02
Estimated Primary Completion Date : 2025-09-01
Estimated Study Completion Date : 2025-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
PRP for Glenohumeral Osteoarthritis

Location Details

NCT05675527

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021