MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ

NCT04033692 | Withdrawn FDA Device

• 1 other identifier: MDRG2017-89MS-64SM
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events

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

  Out to a minimum of 1 year

Secondary Outcomes (3)

• 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

• Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form

  Out to a minimum of 1 year

• Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form

  Out to a minimum of 1 year

Study Arms (1)

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

Interventions

JuggerKnot Mini Soft Anchor DEVICE

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.

JuggerKnot Mini Soft Anchors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive series of subjects implanted with one or more JuggerKnot Mini Soft Anchors in the treatment of temporomandibular joint (TMJ) disease according to the approved indications for 93 total joints. Inclusion/exclusion criteria mirror the indications and contraindications in the IFU.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Kacy Arnold

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 26, 2019
• Study Start: December 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share