Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease

Официальное название

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

Обзор

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

Вмешательства

• Устройство Novosis Putty
  Single Level TLIF surgery with Novosis Putty
• Другое Standard of Care
  Single Level TLIF surgery with standard of care bone graft

Первичные конечные точки

• Overall Success [Срок оценки: 24 months after surgery]

Вторичные конечные точки (10)

• Fusion Success [Срок оценки: 12 months after surgery]
• Overall Success [Срок оценки: 6 and 12 months after surgery]
• Fusion Success [Срок оценки: 6 and 24 months after surgery]
• ODI score [Срок оценки: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
• VAS score [Срок оценки: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
• SF-12 score [Срок оценки: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
• Time to Fusion Success [Срок оценки: From surgery to 60 months after surgery]
• Time to First SSI [Срок оценки: From surgery to 60 months after surgery]
• Treatment satisfaction [Срок оценки: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery]
• Intraoperative variables [Срок оценки: intraoperative]

Критерии участия

Критерии включения

• Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
• Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
• Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
• Male or Female, 21-80 years of age and skeletally mature at the time of surgery
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
• Signed informed consent

Критерии исключения

• Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
• Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
• Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
• Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
• Lactating, pregnant or interested in becoming pregnant in the next 3 years;
• Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
• Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• The Spine Center of Louisiana — Baton Rouge
• LSU Health — Shreveport
• Thomas Jefferson University - Department of Neurological Surgery — Philadelphia
• American Neurospine Institute, PLLC — Frisco
• West Virginia University - Department of Orthopaedics — Morgantown

Идентификаторы

NCT: NCT07017634 · CGNVP002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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