MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Zimmer Biomet

Status: Withdrawn

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

Treatments: Device: JuggerKnot Mini Soft Anchor

Study type: Observational

Funder types: Industry

Identifiers

NCT04033692

MDRG2017-89MS-64SM

Details and patient eligibility

About

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.

Full 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).

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

JuggerKnot Mini Soft Anchors

Description:

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

Treatment:

Device: JuggerKnot Mini Soft Anchor