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Not yet recruiting NCT07316673

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

No phase Interventional Temporomandibular Joint Internal Derangement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fast-Fix-Enhanced Arthroscopic, (Conventional Arthroscopic Suturing Disc Repositioning).
Who it may be relevant to
Registry conditions: Temporomandibular Joint Internal Derangement. Basic parameters: 15 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Procedure Fast-Fix-Enhanced Arthroscopic
    Device: The FasT-Fix system is a medical device designed for an "all-inside" arthroscopic meniscal repair.
  • Procedure (Conventional Arthroscopic Suturing Disc Repositioning)
    Arthroscopic TMJ discopexy using conventional suturing Minimally invasive surgical intervention

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • Joint Symptoms (Clicking and Tenderness) [Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively]
  • Surgical outcomes Total surgical time recorded [Time frame: Intraoperative (day of procedure only)]
  • surgical outcomes Technical Feasibility [Time frame: Intraoperative (day of procedure only)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07316673 · Fast-Fix-Enhanced Arthroscopic

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗