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Status Withdrawn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Status	Withdrawn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

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05510336` - Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement.	N/A
Not yet recruiting	`NCT02960048` - Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .	N/A
Recruiting	`NCT05627830` - Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.	N/A
Recruiting	`NCT03737305` - RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis	N/A
Completed	`NCT05548894` - Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction	N/A
Completed	`NCT05481268` - Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients	N/A
Completed	`NCT06013059` - A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement	N/A
Recruiting	`NCT06426199` - Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement	Phase 4
Completed	`NCT04942743` - Clinical & MRI Finding of TMJ Disk Perforation
Not yet recruiting	`NCT06207955` - I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement	N/A
Completed	`NCT04951895` - Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Completed	`NCT04951830` - Clinical and MRI Finding of The Temporomandibular Joint Stuck Disk
Not yet recruiting	`NCT02992379` - Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint	N/A
Not yet recruiting	`NCT03000790` - Evaluation Lingual Ring Splint	N/A
Recruiting	`NCT05983653` - Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction.	N/A
Recruiting	`NCT06441279` - Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials	N/A