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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Functional improvement assessed by Maximum Mouth Opening (MIO) [Срок оценки: Baseline (preoperative) to 6 months postoperatively (with assessments at 3 months and 6 months; primary endpoint at 6 months]

Вторичные конечные точки (4)

• Clinical outcomes , Pain reduction assessed using the Visual Analogue Scale (VAS) • Improvement of joint symptoms, including clicking and tenderness. [Срок оценки: Baseline (preoperative), 3 months, and 6 months postoperatively]
• Joint Symptoms (Clicking and Tenderness) [Срок оценки: Baseline (preoperative), 3 months, and 6 months postoperatively]
• Surgical outcomes Total surgical time recorded [Срок оценки: Intraoperative (day of procedure only)]
• surgical outcomes Technical Feasibility [Срок оценки: Intraoperative (day of procedure only)]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07316673 · Fast-Fix-Enhanced Arthroscopic

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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