Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 6:43 AM
Study NCT ID:
NCT04033692
Status:
WITHDRAWN
Last Update Posted:
2022-01-27
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Post-market Clinical Follow-Up Study to Collect Safety, Performance and Clinical Benefits Data of the JuggerKnot Mini Soft Anchor for Use in the Maxillofacial Treatment of Temporomandibular Joint (TMJ)
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Manufacturer decided not to proceed with study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: