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NCT05519228 · ClinicalTrials.gov registry record
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow
A clinical trial, sponsored by Zimmer Biomet.
- Completed
- Registry status
- 83
- Enrollment target
NCT05519228 is a clinical trial that has completed, run by Zimmer Biomet. The registered enrollment target is 83 participants.
The verdict
NCT05519228 has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- 83 participants
- Enrollment target
Study Summary
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow. The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).
Interventions
- DEVICE ToggleLoc 2.9 mm Soft Tissue System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2024-02-20 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05519228
The ClinicalTrials.gov registry entry for NCT05519228 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ToggleLoc 2.9 mm Soft Tissue System is the first listed.
NCT05519228 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05519228 about?
NCT05519228 is a clinical study titled "PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm in the Elbow". The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm Soft Tissue System when used for soft tissue to bone fixation ...
What is the current status of trial NCT05519228?
This trial is currently completed. The enrollment target is 83 participants. The study started on 2022-09-12. Estimated completion is 2024-02-20.
What interventions are being tested in trial NCT05519228?
The interventions under investigation include: ToggleLoc 2.9 mm Soft Tissue System (DEVICE).
Who is sponsoring clinical trial NCT05519228?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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