Status:
WITHDRAWN
MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
Lead Sponsor:
Zimmer Biomet
Conditions:
TMJ Disc Disorder
TMJ Pain
Eligibility:
All Genders
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 instrumentatio...
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04033692
Start Date
December 1 2021
End Date
November 1 2022
Last Update
January 27 2022
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