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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: Completed study, sponsored by Zimmer Biomet.
NCT05519228 is a clinical trial that has completed, run by Zimmer Biomet. The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using the Hook test. The Hook test is performed by hooking the finger, that is inserted laterally under the biceps tendon, under the cord-like structure spanning the antecubital fossa with the patient's elbow flexed at 90 degrees. Each case that a Hook test was performed on will be counted as 1
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 |
What the finished NCT05519228 record still lists
NCT05519228 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 83 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ToggleLoc 2.9 mm Soft Tissue System is the first listed.
NCT05519228 does not publish any study locations in the registry export this page uses.
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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