MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT04033692
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Withdrawn
Phase
Start date	December 1, 2021
Completion date	November 1, 2022

View Details

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