Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

Обзор

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

Подробное описание

This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).

Вмешательства

• Устройство iFuse Bedrock technique
  Lumbosacral arthrodesis on 2 or more spinal segments (including at least L4, L5 and S1 vertebrae) associated with a sacroiliac fusion procedure according to the Bedrock technique using the iFuse 3D system and iliac fixation.

Первичные конечные точки

• Change from baseline in self-reported Oswestry Disability Index (ODI) at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Change from baseline in sacroiliac joint pain provocation tests. [Срок оценки: During 12 months]
• Assessment of the Oswestry Disability Index [Срок оценки: 3 and 6 months]
• Improvement of back and leg pains at 3, 6 and 12 months compared to preoperative scores [Срок оценки: 3, 6 and 12 months]
• Change in Patient's quality of life [Срок оценки: 3, 6 and 12 months]
• Proportion of subjects with postoperative SIJ fusion failure [Срок оценки: 12 months]
• Impact of iFuse Bedrock technique on Pelvic Incidence [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on Pelvic Tilt [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on Sacral Slope [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on Lumbar Lordosis [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on Thoracic Kyphosis [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on the Odontoid Hip Axis [Срок оценки: During 12 months]
• Impact of iFuse Bedrock technique on the T1 pelvic angle [Срок оценки: During 12 months]

Критерии участия

Критерии включения

• Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
• Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
• Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
• Patient with a degenerative sacroiliac joint disease requested a fusion procedure;

Критерии исключения

• Major osteoporosis (DEXA scan > 3);
• Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
• Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
• Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
• Currently pregnant or planning pregnancy;
• Prisoner or a ward of the state;
• Subject no willing to participate in the study;
• Subject not affiliated to a social security insurance.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• Hôpitaux Universitaires de Marseille — Marseille

Идентификаторы

NCT: NCT05276024 · 2021-ORT03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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