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NCT05049993 · ClinicalTrials.gov registry record
Pyrocarbon Clinical Follow-up Study
A clinical trial of Avascular Necrosis and Traumatic Arthritis, sponsored by Stryker Trauma and Extremities.
- Active
- Registry status
- 76
- Enrollment target
- 8
- Study locations
NCT05049993: Active study of Avascular Necrosis and Traumatic Arthritis, sponsored by Stryker Trauma and Extremities.
NCT05049993 is a study of Avascular Necrosis and Traumatic Arthritis that is active but no longer recruiting, run by Stryker Trauma and Extremities. The registered enrollment target is 76 participants, below the 292-participant average among 24 other Avascular Necrosis trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05049993, a study of Avascular Necrosis and Traumatic Arthritis, is active but no longer recruiting, sponsored by Stryker Trauma and Extremities.
- ACTIVE NOT RECRUITING
- Registry status
- 76 participants
- Enrollment target
- 8
- Study locations
Study Summary
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Primary Outcome
ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function
Conditions Studied
Interventions
- DEVICE Aequalis Pyrocarbon Humeral Head
Study Locations (8)
Colorado
- HCA HealthONE, LLC - Denver
Florida
- Holy Cross Hospital - Fort Lauderdale
Louisiana
- Tulane University - New Orleans
Maryland
- Southern Maryland Orthopedics - Waldorf
Minnesota
- Allina Health Orthopedics - Minneapolis
Missouri
- Missouri Orthopaedic Institute - Columbia
North Carolina
- Duke University - Durham
Oregon
- Southern Oregon Orthopedics - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2027-12-31 |
What the registry record for NCT05049993 still lists
NCT05049993 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 292-participant average among 24 other Avascular Necrosis trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Avascular Necrosis appearing as the primary indexed condition, and to 1 intervention - of which Aequalis Pyrocarbon Humeral Head is the first listed.
NCT05049993 lists 8 locations in 8 states (Colorado, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT05049993 about?
NCT05049993 is a clinical study titled "Pyrocarbon Clinical Follow-up Study". The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will ...
What is the current status of trial NCT05049993?
This trial is currently active not recruiting. The enrollment target is 76 participants. The study started on 2021-10-27. Estimated completion is 2027-12-31.
What conditions does trial NCT05049993 study?
This clinical trial studies the following conditions: Avascular Necrosis, Traumatic Arthritis, Osteoarthritis of the Shoulder.
What interventions are being tested in trial NCT05049993?
The interventions under investigation include: Aequalis Pyrocarbon Humeral Head (DEVICE).
Who is sponsoring clinical trial NCT05049993?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05049993 being conducted?
This trial has 8 study locations across Colorado, Florida, Louisiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05049993's enrollment target sits among peer trials
76 21st of 24 higher than 4 of 24 other Avascular Necrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Avascular Necrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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