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NCT03880955 · ClinicalTrials.gov registry record
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
A clinical trial, sponsored by Stryker Trauma and Extremities.
- Terminated
- Registry status
- 102
- Enrollment target
NCT03880955: Clinical Trial study, sponsored by Stryker Trauma and Extremities.
NCT03880955 is a clinical trial that was terminated before completion, run by Stryker Trauma and Extremities. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03880955 was terminated before completion, sponsored by Stryker Trauma and Extremities.
- TERMINATED
- Registry status
- 102 participants
- Enrollment target
Study Summary
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.
Primary Outcome
This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indic
Interventions
- DEVICE ReUnion RSA System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2023-12-13 |
Why NCT03880955 stopped before completion
NCT03880955 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which ReUnion RSA System is the first listed.
NCT03880955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03880955 about?
NCT03880955 is a clinical study titled "A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System". This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which en...
What is the current status of trial NCT03880955?
This trial is currently terminated. The enrollment target is 102 participants. The study started on 2019-06-25. Estimated completion is 2023-12-13.
What interventions are being tested in trial NCT03880955?
The interventions under investigation include: ReUnion RSA System (DEVICE).
Who is sponsoring clinical trial NCT03880955?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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