At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and the JuggerLoc™ Soft Tissue Systems (Implants and Instrumentation) in the Shoulder - A Multicenter Retrospective Study
In Brief
An observational study evaluating ToggleLoc 2.9 mm soft tissue device and JuggerLoc soft tissue device for Bankart Lesions and 6 related conditions. Completed, enrolled 214 participants across 3 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
The ToggleLoc 2.9 mm Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.
The JuggerLoc Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation.