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MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

Sponsor
Zimmer Biomet (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04033692
Collaborator
(none)
0
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: JuggerKnot Mini Soft Anchor

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).

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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)
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
JuggerKnot Mini Soft Anchors

Patients who have been implanted with the JuggerKnot Mini Soft Anchor 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

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.

Outcome Measures

Primary Outcome Measures

  1. Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events [Out to a minimum of 1 year]

    Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.

Secondary Outcome Measures

  1. Device performance and Clinical Benefits Assessed by a Pain Assessment. and Temporomandibular Joint Function of the Pain Assessment Survey Case Report Form. [Out to a minimum of 1 year]

    Pain Assessment is used to evaluate a patients pain from 0 to 10, 0 representing no pain at all and 10 representing the worse pain imaginable.

  2. Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form [Out to a minimum of 1 year]

    The TMJ Function portion of the Pain Assessment Survey is assessed by if the patient experiences Temporomandibular Joint Clicking or Popping Noise. The Joint Clicking or Popping noise is evaluated as a Yes the joint click when opening and closing the mouth, or No the joint does not click when opening and closing the mouth on either the left or right side.

  3. Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form [Out to a minimum of 1 year]

    The Headache portion of the Pain Assessment Survey is evaluated as, Yes the patient has headaches, or No the patient does not have headaches. If they check yes the survey asks on which side of the headache occurs and in which location. Location options are: Front, Posterior, Temporal or Top of the head.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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 Criteria:

  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zimmer Biomet

Investigators

  • Study Director: Kacy Arnold, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT04033692
Other Study ID Numbers:
  • MDRG2017-89MS-64SM
First Posted:
Jul 26, 2019
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Temporomandibular Joint Disorders

Study Results

No Results Posted as of Jan 27, 2022