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NCT05584553 · ClinicalTrials.gov registry record
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
A clinical trial, sponsored by Zimmer Biomet.
- Completed
- Registry status
- 214
- Enrollment target
NCT05584553: Completed study, sponsored by Zimmer Biomet.
NCT05584553 is a clinical trial that has completed, run by Zimmer Biomet. The registered enrollment target is 214 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05584553 has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- 214 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 and the JuggerLoc Soft Tissue Systems when used for soft tissue to bone fixation in the shoulder. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the shoulder. 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 shoulder. The principal investigator will clinically evaluate the study shoulder to assess if soft tissue to bone healing has occurred using an assessment of pain. Healing was assessed by clinical examination at a minimum of 12 months post-operation. Soft tissue-to-bone healing was evaluated through clinical assessment at follow-up. Healing was defined as restoration of tendon attachment to bone without visible gap, pain,
Interventions
- DEVICE ToggleLoc 2.9 mm soft tissue device
- DEVICE JuggerLoc soft tissue device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2024-06-30 |
What the finished NCT05584553 record still lists
NCT05584553 is an observational study that tracks outcomes without assigning an intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which ToggleLoc 2.9 mm soft tissue device is the first listed.
NCT05584553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05584553 about?
NCT05584553 is a clinical study titled "PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder". 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 and the JuggerLoc Soft Tissue Systems when used for soft tissu...
What is the current status of trial NCT05584553?
This trial is currently completed. The enrollment target is 214 participants. The study started on 2022-12-02. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT05584553?
The interventions under investigation include: ToggleLoc 2.9 mm soft tissue device (DEVICE), JuggerLoc soft tissue device (DEVICE).
Who is sponsoring clinical trial NCT05584553?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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