A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical Outcomes

January 2, 2026 updated by: Wajmah Sayed Karim Al Sayed, Cairo University

A Prospective Randomized Clinical Trial Comparing a Fast Fix Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Clinical, Functional, and Surgical Outcomes

This prospective randomized clinical trial evaluates the effectiveness of a Fast Fix-enhanced arthroscopic system compared with conventional arthroscopic suturing for temporomandibular joint disc repositioning in patients with TMJ internal derangement. Patients are randomly allocated into two groups and assessed for functional improvement (maximum mouth opening), pain reduction, joint symptoms, and surgical performance outcomes over a 6-month follow-up period. The study aims to determine whether the Fast Fix-enhanced technique provides superior clinical, functional, and surgical outcomes compared to conventional arthroscopic suturing

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria.

  • Age ≥ 18 years.
  • Both sexes.
  • Patients with TMJ internal derangement (disc displacement without reduction).
  • Patients indicated for arthroscopic disc repositioning following failure of conservative management.

Exclusion Criteria

  • Previous TMJ surgery on the affected joint.
  • Rheumatoid arthritis, systemic inflammatory joint disease, or other TMJ pathology (tumor, fracture, infection)
  • Severe degenerative joint disease (osteoarthritis grade V) or ankylosis.
  • Patients are unable to comply with follow-up assessments or MRI evaluation.
  • Patients with TMDS are secondary to malocclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast-Fix-Enhanced Arthroscopic Disc Repositioning
Procedure: Fast-Fix-Enhanced Arthroscopic
Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair.
Active Comparator: Conventional Arthroscopic Suturing Disc Repositioning
Procedure: (Conventional Arthroscopic Suturing Disc Repositioning)

Arthroscopic TMJ discopexy using conventional suturing

Minimally invasive surgical intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement assessed by Maximum Mouth Opening (MIO)
Time Frame: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months
MIO is measured as the maximal interincisal distance (in millimeters) using a ruler or digital caliper, with the primary endpoint being the change from baseline to 6 months postoperatively.
Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness.
Time Frame: Baseline (preoperative), 3 months, and 6 months postoperatively
Pain intensity assessed using the 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents unbearable pain.
Baseline (preoperative), 3 months, and 6 months postoperatively
Joint Symptoms (Clicking and Tenderness)
Time Frame: Baseline (preoperative), 3 months, and 6 months postoperatively
Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report.
Baseline (preoperative), 3 months, and 6 months postoperatively
Surgical outcomes Total surgical time recorded
Time Frame: Intraoperative (day of procedure only)
Total surgical time recorded intraoperatively from incision to completion of disc fixation, measured in minutes
Intraoperative (day of procedure only)
surgical outcomes Technical Feasibility
Time Frame: Intraoperative (day of procedure only)
Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique.
Intraoperative (day of procedure only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Estimated)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Fast-Fix-Enhanced Arthroscopic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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