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NCT05160441 · ClinicalTrials.gov registry record · Phase 3
Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis
A Phase 3 study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT05160441 is a Phase 3 study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 50 participants.
The verdict
NCT05160441, a Phase 3 study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.
Interventions
- BIOLOGICAL Platelet Rich Plasma Injection
- BIOLOGICAL Corticosteroid Injection
- BIOLOGICAL Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2025-05-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05160441
The ClinicalTrials.gov registry entry for NCT05160441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Platelet Rich Plasma Injection is the first listed.
NCT05160441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05160441 about?
NCT05160441 is a clinical study titled "Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis". Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the ...
What is the current status of trial NCT05160441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2022-09-26. Estimated completion is 2025-05-08.
What interventions are being tested in trial NCT05160441?
The interventions under investigation include: Platelet Rich Plasma Injection (BIOLOGICAL), Corticosteroid Injection (BIOLOGICAL), Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure (BIOLOGICAL).
Who is sponsoring clinical trial NCT05160441?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
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