NCT05675527 PRP for Glenohumeral Osteoarthritis
| NCT ID | NCT05675527 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Shoulder Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 135 participants in total. It began in 2023-05-02 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05675527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Shoulder Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05675527 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05675527 currently recruiting?
Yes, NCT05675527 is actively recruiting participants. Contact the research team at kirschnerj@hss.edu for enrollment information.
Where is the NCT05675527 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05675527 clinical trial?
NCT05675527 is sponsored by Hospital for Special Surgery, New York. The trial plans to enroll 135 participants.