Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

Официальное название

Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

Обзор

Study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. Eligible patients undergoing ACDF (see inclusion criteria listed below) will be randomized to an Intervention or Control Group, which will differ according to the interbody cage used during the procedure. In the Intervention Group (100 patients), Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted at each treated level. In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. Interbody cages used in the Control Group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. There will be no blinding to the type of implant used. Standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). Clinical and radiographic outcomes in the Intervention and Control Groups will be directly compared.

Подробное описание

Aim 1: Examine the effect of nanoLOCK technology on rates of postoperative dysphagia after ACDF.

Aim 2: Evaluate the effect of nanoLOCK technology on radiographic fusion.

Aim 3: Evaluate how nanoLOCK technology influences the development of radiographic adjacent segment disease.

Вмешательства

• Устройство Titan nanoLOCK interbody cage
  Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
• Устройство ACDF interbody cage
  Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology

Первичные конечные точки

• Number of patient reported dysphagia events measured by Eat-10 assessment tool [Срок оценки: Postoperative at Day 1]
• Number of patient reported dysphagia events measured by Eat-10 assessment tool [Срок оценки: 2 weeks following surgery]
• Number of patient reported dysphagia events measured by Eat-10 assessment tool [Срок оценки: 3 months following surgery]
• Number of patient reported dysphagia events measured by Eat-10 assessment tool [Срок оценки: 6 months following surgery]
• Number of patient reported dysphagia events measured by Eat-10 assessment tool [Срок оценки: 12 months following surgery]
• Dysphagia as measured by SWAL-QOL assessment tool [Срок оценки: Postoperative at day 1]
• Dysphagia as measured by SWAL-QOL assessment tool [Срок оценки: 2 weeks following surgery]
• Dysphagia as measured by SWAL-QOL assessment tool [Срок оценки: 3 months following surgery]
• Dysphagia as measured by SWAL-QOL assessment tool [Срок оценки: 6 months following surgery]
• Dysphagia as measured by SWAL-QOL assessment tool [Срок оценки: 12 months following surgery]

Вторичные конечные точки (12)

• Percentage of participants experiencing neck pain [Срок оценки: Baseline (Pre-op)]
• Percentage of participants experiencing neck pain [Срок оценки: 6 weeks following surgery]
• Percentage of participants experiencing neck pain [Срок оценки: 3 months following surgery]
• Percentage of participants experiencing neck pain [Срок оценки: 6 months following surgery]
• Percentage of participants experiencing neck pain [Срок оценки: 12 months following surgery]
• Percentage of participants showing functional improvement [Срок оценки: Baseline (Pre-op)]
• Percentage of participants showing functional improvement [Срок оценки: 6 weeks following surgery]
• Percentage of participants showing functional improvement [Срок оценки: 3 months following surgery]
• Percentage of participants showing functional improvement [Срок оценки: 6 months following surgery]
• Percentage of participants showing functional improvement [Срок оценки: 12 months following surgery]
• Number of participants who experienced overall complications [Срок оценки: 3 years following surgery]
• Percentage of participants reporting functional outcomes as measured by PROMIS-29 [Срок оценки: Baseline (Pre-op)]

Критерии участия

Критерии включения

• Subjects 18 years of age or older
• Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels)
• Subjects with no prior history of cervical spine surgery
• Subjects with complete/usable data

Критерии исключения

• Subjects under the age of 18
• Subjects not undergoing ACDF surgery
• Subjects with prior cervical spine surgery
• Subjects with cervical neoplastic or infectious disease pathology
• Subjects with cervical trauma pathology
• ACDF performed at C2-3
• Subjects with incomplete/unusable data

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT05762055 · STU-2022-1092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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