MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Withdrawn

• Conditions: TMJ Disease; TMJ Disc Disorder; TMJ Sounds on Opening/Closing the Jaw; TMJ Pain
• Interventions: Device: JuggerKnot Mini Soft Anchor

• Registration Number: NCT04033692
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JuggerKnot Mini Soft Anchors	JuggerKnot Mini Soft Anchor	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Device performance and Clinical Benefits Assessed by a Pain Assessment. and Temporomandibular Joint Function of the Pain Assessment Survey Case Report Form.	Out to a minimum of 1 year	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.
Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form	Out to a minimum of 1 year	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.
Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form	Out to a minimum of 1 year	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.