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NCT Number: 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

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

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Key information

Conditions

Temporomandibular Joint Internal Derangement

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fast-Fix-Enhanced Arthroscopic

Procedure

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

(Conventional Arthroscopic Suturing Disc Repositioning)

Procedure

Arthroscopic TMJ discopexy using conventional suturing

Minimally invasive surgical intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

wajmah Al Sayed, PHD

CONTACT

[email protected]

0509560055

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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