Health Trials

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

ConditionTemporomandibular Joint Internal Derangement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-75
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fast-Fix-Enhanced Arthroscopic

    Procedure/Surgery

    Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair.

  • (Conventional Arthroscopic Suturing Disc Repositioning)

    Procedure/Surgery

    Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Fast-Fix-Enhanced Arthroscopic Disc RepositioningExperimental treatment 1 intervention
Group B: Conventional Arthroscopic Suturing Disc RepositioningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional improvement assessed by Maximum Mouth Opening (MIO)

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.

Time frame
Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months

Secondary outcomes

1

Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness.

Pain intensity assessed using the 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents unbearable pain.

Time frame
Baseline (preoperative), 3 months, and 6 months postoperatively
2

Joint Symptoms (Clicking and Tenderness)

Clinical evaluation of TMJ joint sounds (clicking) and joint tenderness through physical examination and patient report.

Time frame
Baseline (preoperative), 3 months, and 6 months postoperatively
3

Surgical outcomes Total surgical time recorded

Total surgical time recorded intraoperatively from incision to completion of disc fixation, measured in minutes

Time frame
Intraoperative (day of procedure only)
4

surgical outcomes Technical Feasibility

Surgeon's intraoperative assessment of the feasibility of disc fixation using the assigned arthroscopic technique.

Time frame
Intraoperative (day of procedure only)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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