MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Study Overview
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Brief Summary
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The objective of this retrospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the JuggerKnot Mini Soft Anchor (implant and instrumentation) when used for soft tissue to bone fixation in the treatment of temporomandibular joint (TMJ) surgery. Safety, performance, and clinical benefits will be evaluated at the following time points: pre op, 6 weeks, 3 months and 1-year follow-up. JuggerKnot Mini has been on the market since November of 2011.

Detailed Description
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The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

Official Title
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Post-market Clinical Follow-Up Study to Collect Safety, Performance and Clinical Benefits Data of the JuggerKnot Mini Soft Anchor for Use in the Maxillofacial Treatment of Temporomandibular Joint (TMJ)

Conditions
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TMJ Pain, TMJ Disc Disorder, TMJ Sounds on Opening/Closing the Jaw, TMJ Disease

Intervention / Treatment
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* Device: JuggerKnot Mini Soft Anchor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implanted with one or more JuggerKnot Mini Soft Anchor(s) with either a 2-0 or 3-0 suture Must have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is required for surgical stabilization of the TMJ articular disc Exclusion Criteria: Local Infection. Patient conditions including blood supply limitations and insufficient quantity or quality off bone or soft tissue. Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so. Foreign body sensitivity where material sensitivity is suspected. Off-label use. Sepsis. Patient is a prisoner. Patient is a known alcohol or drug abuser.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JuggerKnot Mini Soft Anchors<br>Patients who have been implanted with the JuggerKnot Mini Soft Anchor who have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is require for surgical stabilization of the TMJ articular disc | Device: JuggerKnot Mini Soft Anchor<br>* Patient who have been implanted with one or more JuggerKnot Mini Soft Anchor(s) who have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is require for surgical stabilization of the TMJ articular disc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events | Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events. | Out to a minimum of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance and Clinical Benefits Assessed by a Pain Assessment. and Temporomandibular Joint Function of the Pain Assessment Survey Case Report Form. | Pain Assessment is used to evaluate a patients pain from 0 to 10, 0 representing no pain at all and 10 representing the worse pain imaginable. | Out to a minimum of 1 year | 
| Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form | The TMJ Function portion of the Pain Assessment Survey is assessed by if the patient experiences Temporomandibular Joint Clicking or Popping Noise. The Joint Clicking or Popping noise is evaluated as a Yes the joint click when opening and closing the mouth, or No the joint does not click when opening and closing the mouth on either the left or right side. | Out to a minimum of 1 year | 
| Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form | The Headache portion of the Pain Assessment Survey is evaluated as, Yes the patient has headaches, or No the patient does not have headaches. If they check yes the survey asks on which side of the headache occurs and in which location. Location options are: Front, Posterior, Temporal or Top of the head. | Out to a minimum of 1 year |