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Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy

NCT06520917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-25

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate a guide device (locator-positioner LOPO guide device) that is intended to aid the surgeon in temporomandibular joint (TMJ) arthroscopy. The aim of the device is to help the surgeon introduce the arthroscope and working cannula into the TMJ space. The trial evaluates the accuracy and safety of the device.

The main questions it aims to answer are:

* Does the LOPO guide device increase the accuracy of inserting the arthroscope and working cannula into the temporomandibular joint?
* Does the number of attempts to correctly place the working cannula relative to the arthroscope decrease?
* Does the overall time of surgery decrease when using the LOPO device?
* Does the device pose new surgical risks to temporomandibular joint arthroscopy?

The LOPO device was tried on anatomical models and proved to be very accurate. The present study recruits up to 10 patients to participate in this experiment. IRB approval and Ministry of Health approval have been given for conducting the clinical trial in 10 patients.

Participants will:

* Have a diagnosis of temporomandibular closed lock based on clinical and imaging findings.
* Undergo temporomandibular joint arthroscopy with the aid of the LOPO device.
* Visit the clinic for routine follow-up visits after roughly 1 week, 3 weeks, 2 months, and 6 months postoperatively, and at each visit be evaluated for maximal mouth opening and severity of pain on a 1-10 VAS.

Conditions

  • Temporomandibular Joint Disc Displacement
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Interventions

DEVICE

Locator-Positioner (LOPO) Guide Device

Patients underwent temporomandibular joint arthroscopy with the aid of the LOPO guide device

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Waseem Abboud, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2019-06-30
Completion
2020-01-18

Countries

  • Israel

Study Locations

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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 NCT06520917 on ClinicalTrials.gov