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

NCT ID: NCT07316673

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Temporomandibular Joint Internal Derangement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fast-Fix-Enhanced Arthroscopic Disc Repositioning

Group Type EXPERIMENTAL

Fast-Fix-Enhanced Arthroscopic

Intervention Type PROCEDURE

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

Conventional Arthroscopic Suturing Disc Repositioning

Group Type ACTIVE_COMPARATOR

(Conventional Arthroscopic Suturing Disc Repositioning)

Intervention Type PROCEDURE

Arthroscopic TMJ discopexy using conventional suturing

Minimally invasive surgical intervention

Interventions

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Fast-Fix-Enhanced Arthroscopic

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

Intervention Type PROCEDURE

(Conventional Arthroscopic Suturing Disc Repositioning)

Arthroscopic TMJ discopexy using conventional suturing

Minimally invasive surgical intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Wajmah Sayed Karim Al Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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wajmah Al Sayed, PHD

Role: CONTACT

0509560055

Other Identifiers

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Fast-Fix-Enhanced Arthroscopic

Identifier Type: -

Identifier Source: org_study_id

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