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MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

NCT04033692 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-01-27

No results posted yet for this study

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.

Conditions

  • TMJ Disc Disorder
  • TMJ Pain
  • TMJ Sounds on Opening/Closing the Jaw
  • TMJ Disease

Interventions

DEVICE

JuggerKnot Mini Soft Anchor

Patient who have been implanted with one or more JuggerKnot Mini Soft Anchor(s) 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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Kacy Arnold · Zimmer Biomet

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-10-01
Completion
2022-11-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033692 on ClinicalTrials.gov