PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder

Study Overview
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Brief Summary
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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).

Detailed Description
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The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue devices consist of non-resorbable devices intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue to bone fixation. The clinical purpose is to restore the function and flexibility of the shoulder requiring soft tissue to bone fixation and to relieve pain that cannot be controlled by other treatments. Three sites will be involved in this study. The aim is to include a total of 206 (103 cases operated with the ToggleLoc 2.9 mm and 103 cases operated with the JuggerLoc in the shoulder) consecutive series cases. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preop and intraop will be available in medical notes. The patients will be asked to complete patient questionnaires during a minimum 1 year follow up visit/phone call. In addition, any complications and adverse events that occured since the surgery will also be collected during the follow-up visit/phone call.

Official Title
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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

Conditions
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Deltoid Repair, Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction, Rotator Cuff Tear Repair, Biceps Tendon Disorder

Intervention / Treatment
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* Device: ToggleLoc 2.9 mm soft tissue device
* Device: JuggerLoc soft tissue device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ToggleLoc 2.9 mm soft tissue device<br>Patients who already received the ToggleLoc 2.9 mm soft tissue device in the shoulder. No additional surgery will be performed. | Device: ToggleLoc 2.9 mm soft tissue device<br>* 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.<br>|
| JuggerLoc soft tissue device<br>Patients who already received the JuggerLoc soft tissue device in the shoulder. No additional surgery will be performed. | Device: JuggerLoc soft tissue device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue to bone healing in the shoulder | 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 a assessment of pain. Pain will be measured from none (no pain) to severe. | From operation to the study completion, minimum 1 year post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions | Safety will be evaluated by recording and analyzing the incidence of revisions. A Kaplan Meier survival curve will be calculated. The Kaplan-Meier involves computing of probabilities of occurrence of revision at a certain point of time. | From operation to the study completion, minimum 1 year post-op. | 
| EuroQol five-dimensional Health Questionnaire (EQ-5D-5L) | Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). The EuroQol five-dimensional Health Questionnaire (EQ-5D-5L): is a generic instrument. The EQ is scored on a 0 to 100 mm scale representing the worst... and the best health you can imagine, respectively. | From pre-operative to the study completion, minimum 1 year post-op. | 
| Oxford Shoulder Score (OSS) | Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs). the Oxford Shoulder Score (OSS) is a 12-item, each with 5 potential answers specifically designed and developed for assessing outcomes of shoulder surgery. The score will be on a scale from 0 (worst) to 48 (best). | From pre-operative to the study completion, minimum 1 year post-op. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Market Clinical Follow-Up Study, Medical Device, Performance, Clinical Benefits, Safety