JuggerKnot With Broadband PMCF Study

Study Overview
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Brief Summary
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The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.

Official Title
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JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study

Conditions
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Shoulder Injuries, Hip Injuries, Foot Injury, Ankle Injuries, Knee Injuries

Intervention / Treatment
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* Device: Juggerknot with Broadband tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated; Male or non-pregnant female ≥ 18 years of age; Willing to provide informed consent and comply with the required follow-up period. Exclusion Criteria: Infection where implantation of the device would be compromised; Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue; Known allergy to one of the JuggerKnot with BroadBand components; Mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients requiring soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip<br> | Device: Juggerknot with Broadband tape<br>* The JuggerKnot system is comprised of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue to bone fixation by bunching against the bone when deployed. The anchor sleeve material is polyester. Suture materials are ultra-high molecular weight polyethylene. The device has 510K FDA clearance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Defined as freedom from reintervention due to JuggerKnot with BroadBand failure. Absence of device migration loosening or pull-out. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical and Procedural Success | Successful bone to soft tissue fixation without complications such as anchor pull-out, suture breakage or suture pull through. | Intraoperatively | 
| PROMIS Physical Function Score | The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. | Change from baseline to 6 months | 
| VAS Pain Score | A VAS consists of a line, often 10 cm long, with verbal anchors at either end, similar to an NRS (e.g., no pain on the far left and the most intense pain imaginable on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. | Change from baseline to 6 months | 
| Change in degrees of Range of Motion (ROM) measured by Goniometer | The extent or limit to which a part of the body can be moved around a joint or a fixed point. ROM will depend on the anatomy being studies. ROM will be measured by goniometer. | Change from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft tissue fixation