Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy

NCT06520917 | Completed DMC

• 2 other identifiers: SMC-4657-1793765
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Arthroscopy; Arthroscopic surgery; Temporomandibular joint closed lock; Temporomandibular joint

Outcome Measures

Primary Outcomes (2)

• Number of attempts made to successfully insert the working cannula into the joint space

  After puncturing the skin and advancing to the joint, any partial or complete withdrawal of the cannula followed by a change of vector or depth was considered an additional attempt. Confirmation of successful insertion was based on visualizing the working cannula by the arthroscope (i.e. observing the working cannula on the monitor).

  This outcome is reported during the surgical procedure, as the number of attempts is counted by a resident in the operating room

• The duration of time between the arthroscope's insertion into the joint cavity and the initial appearance of the working cannula on the monitor.

  The time that elapsed from the point when the arthroscope was inserted in the joint space and the point when the working cannula was seen on the monitor.

  This outcome is reported during the surgical procedure, as the time is measured by a resident in the operating room

Study Arms (1)

Performing temporomandibular joint arthroscopy with the aid of the Locator-Positioner (LOPO) Device

EXPERIMENTAL

The patients underwent the arthroscopic procedure of the temporomandibular joint with the guidance of the Locator-Positioner Device

Device: Locator-Positioner (LOPO) Guide Device

Interventions

Locator-Positioner (LOPO) Guide Device DEVICE

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

Performing temporomandibular joint arthroscopy with the aid of the Locator-Positioner (LOPO) Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with closed lock of the temporomandibular joint (Wilkes stage III internal derangement) based on clinical examination and MRI findings.
• Subjects accepting to participate in the study and undergoing the arthroscopic procedure with the aid of the LOPO device.
• Subjects that are adults (\> 18 years), not pregnant, and of sound judgement.

You may not qualify if:

• Diagnosis of other temporomandibular joint disorders.
• Minor patients under 18 years.
• Pregnant patients.
• Subjects lacking sound judgement.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Related Publications (7)

• Abboud WA. Novel guide device for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2020 Sep;49(9):1217-1219. doi: 10.1016/j.ijom.2020.02.013. Epub 2020 Mar 11.

  PMID: 32171619 BACKGROUND

• Monje Gil F, Hernandez Vila C, Moyano Cuevas JL, Lyra M, Pagador JB, Sanchez Margallo FM. Validation of a simulator for temporomandibular joint arthroscopy. Int J Oral Maxillofac Surg. 2016 Jul;45(7):836-41. doi: 10.1016/j.ijom.2016.01.010. Epub 2016 Feb 3.

  PMID: 26850940 BACKGROUND

• Verde L, Munoz-Guerra MF, Rodriguez-Campo FJ, Escorial V. Temporomandibular Joint: Approach to the Intermediate Space by Triangulation With Transillumination Reference. J Oral Maxillofac Surg. 2023 Jun;81(6):684-688. doi: 10.1016/j.joms.2023.02.008. Epub 2023 Mar 6.

  PMID: 36893793 BACKGROUND

• Peserico-DalFarra P, Gagliardi-Lugo AF. Training simulation for oral and maxillofacial surgeons based on the techniques of arthroscopy in the temporomandibular joint. Br J Oral Maxillofac Surg. 2019 Nov;57(9):929-931. doi: 10.1016/j.bjoms.2019.08.003. Epub 2019 Aug 22.

  PMID: 31445774 BACKGROUND

• Slavin AB. Comments on "single-cannula technique for operative arthroscopy using holmium:YAG laser". J Oral Maxillofac Surg. 2012 May;70(5):1014; author reply 1014. doi: 10.1016/j.joms.2012.02.011. No abstract available.

  PMID: 22538020 BACKGROUND

• McCain JP, Hossameldin RH. Advanced arthroscopy of the temporomandibular joint. Atlas Oral Maxillofac Surg Clin North Am. 2011 Sep;19(2):145-67. doi: 10.1016/j.cxom.2011.06.001. No abstract available.

  PMID: 21878249 BACKGROUND

• Abboud W, Reiter S, Friedman-Rubin P, Shamir D, Peleg O. Guide device to assist in performing arthroscopic surgery of the temporomandibular joint-a preliminary study. J Oral Facial Pain Headache. 2025 Mar;39(1):128-133. doi: 10.22514/jofph.2025.012. Epub 2025 Mar 12.

  PMID: 40129430 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Study Officials

• Waseem Abboud, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients that were included in the study underwent temporomandibular joint arthroscopy using the Locator-Positioner Device, as opposed to the usual/classic procedure of temporomandibular joint arthroscopy without the aid of the Locator-Positioner Device

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: August 31, 2018
• Primary Completion: June 30, 2019
• Study Completion: January 18, 2020
• Last Updated: July 25, 2024

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data is available. It will remain available for 1 year after publishing the study in an international medical journal.
• Access Criteria: A researcher that identifies with an ORCID ID and an email of an academic institution identified by the email's suffix.

Locations

IL (1)