Clinical trial NCT04033692: MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: TMJ Disc Disorder
TMJ Pain
TMJ Sounds on Opening/Closing the Jaw
TMJ Disease
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
timeFrame: Out to a minimum of 1 year
Secondary outcomes:
measure: Device performance and Clinical Benefits Assessed by a Pain Assessment. and Temporomandibular Joint Function of the Pain Assessment Survey Case Report Form.
timeFrame: Out to a minimum of 1 year
measure: Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form
timeFrame: Out to a minimum of 1 year
measure: Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form
timeFrame: Out to a minimum of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold
role: STUDY_DIRECTOR
References: