MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-11-01

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.

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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JuggerKnot Mini Soft Anchors

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

JuggerKnot Mini Soft Anchor

Intervention Type DEVICE

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.

Interventions

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JuggerKnot Mini Soft Anchor

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.

Intervention Type DEVICE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes