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NCT04089371 · ClinicalTrials.gov registry record
A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
A clinical trial, sponsored by Stryker Trauma and Extremities.
- Terminated
- Registry status
- 10
- Enrollment target
NCT04089371: Clinical Trial study, sponsored by Stryker Trauma and Extremities.
NCT04089371 is a clinical trial that was terminated before completion, run by Stryker Trauma and Extremities. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04089371 was terminated before completion, sponsored by Stryker Trauma and Extremities.
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient 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 Total Shoulder Arthroplasty (TSA)
- DEVICE ReUnion Reverse Shoulder Arthroplasty (RSA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2022-07-08 |
Why NCT04089371 stopped before completion
NCT04089371 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which ReUnion Total Shoulder Arthroplasty (TSA) is the first listed.
NCT04089371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04089371 about?
NCT04089371 is a clinical study titled "A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System". This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, ...
What is the current status of trial NCT04089371?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2019-10-01. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT04089371?
The interventions under investigation include: ReUnion Total Shoulder Arthroplasty (TSA) (DEVICE), ReUnion Reverse Shoulder Arthroplasty (RSA) (DEVICE).
Who is sponsoring clinical trial NCT04089371?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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