PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
Completed
Conditions studied: Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Tear Repair, Biceps Tendon Disorder
In brief
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).
Key facts
- Study ID
- NCT05584553
- Run by
- Zimmer Biomet
- People needed
- 214
- Starts
- 2022-12-02
- Expected to finish
- 2024-06-30
- Last updated by the study team
- 2025-11-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients that received the ToggleLoc 2.9 mm and/or the JuggerLoc Soft Tissue devices for soft tissue to bone fixation in the shoulder.
- Patients 18 years or older and skeletally mature.
- Patients capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
You may not qualify if…
- Infection.
- Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue.
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
- Patients who are unwilling or unable to give consent, or to comply with the follow-up program.
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Off-label use.
Where it is running
- Advanced Bone and Joint — City of Saint Peters, Missouri, United States
- Centro Médico Quirónsalud — Alicante, Spain
- Hospital Universitario Quirónsalud — Madrid, Spain
Full record on ClinicalTrials.gov
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