FIBERGRAFT Aeridyan Posterolateral Fusion Study

Официальное название

A Post-market, Prospective, Controlled, Multicenter Clinical Study to Evaluate Radiographic Fusion of FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute in Subjects Who Undergo a Lumbar Posterolateral Fusion Surgery

Обзор

This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level instrumented lumbar posterolateral fusion surgery. This clinical study will be conducted at up to 10 clinical sites within the United States.

Подробное описание

To evaluate radiographic and clinical outcomes of subjects undergoing a 1-3 level instrumented posterior fusion with DePuy Synthes FIBERGRAFT Aeridyan Matrix or Demineralized Bone Matrix in the posterolateral lumbar spine.

Вмешательства

• Устройство FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute
  FIBERGRAFT™ Aeridyan Matrix is a next generation synthetic bone graft that is resorbable, bioactive, and osteoconductive. FIBERGRAFT Aeridyan Matrix is composed of ultra-porous 45S5 bioactive glass granules, boron-based bioactive glass microspheres, and bovine type 1 collagen. The granules are made entirely of 45S5 bioactive glass fibers and feature a porous outer shell encasing an intricate nest of micro- and nano- fibers and microspheres. The nonporous microspheres are made entirely of boron-b
• Устройство Demineralized Bone Matrix
  Demineralized Bone Matrix is to be used with bone marrow aspirate and mixed with autograft bone in accordance with approved indications per the IFU

Первичные конечные точки

• Primary outcome [Срок оценки: 12 Months]

Вторичные конечные точки (5)

• Secondary Outcome [Срок оценки: 12 Months]
• Secondary Outcome [Срок оценки: 24 months]
• Secondary Outcome [Срок оценки: 6 months]
• Secondary Outcome [Срок оценки: 6 months and 12 months]
• Secondary Outcome [Срок оценки: Through study completion]

Критерии участия

Критерии включения

• Subjects who require a 1-3 level instrumented PLF fusion in the lumbar spine in conjunction with a 1 to 2 consecutive level posterior lumbar interbody fusion procedure between L1-S1.
• Skeletally mature subjects at least 18 years of age at the time of consenting.
• Willing to provide voluntary written informed consent prior to participation in the clinical study.

Критерии исключения

• Subjects who had previous fusion surgery at the index level(s).
• Requiring a Posterolateral Fusion in the lumbar spine at more than three levels and/or an interbody fusion at more than two levels
• Subjects who have demonstrated allergy or foreign body sensitivity to the implant or graft material.
• Pregnant subjects or planning to become pregnant within the next 24 months.
• Subjects diagnosed with severe osteoporosis which may prevent adequate fixation and thus preclude the use of these or any other orthopedic implant.
• Subjects diagnosed with severe instabilities, vertebral fractures, spinal tumors.
• Subjects who have an uncontrolled systemic or metabolic disease which, in the Investigator's opinion, would compromise their health, safety, or ability to participate or follow-up in this clinical study.
• Subjects requiring use of an implantable bone graft stimulator or external bone graft stimulator.
• Subjects that have infection or osteomyelitis at the graft site. Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Any medical or surgical condition that precludes the potential benefit of spinal surgery, in the opinion of the Investigator.
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism resulting in a lack of subject cooperation.
• Subjects unable to comply, and/or in the Investigator's opinion unable to comply, with the requirements of participation in the clinical study.
• Enhanced Demineralized Bone Matrix product for the grafting control used within the posterolateral spine
• Use of Bone Morphogenetic Protein (BMP) grafting material within the interbody cage(s).
• Body Mass Index (BMI) ≥ 45
• Unilateral posterior instrumentation
• Subject is currently involved in a workers' compensation claim.
• Subject has participated in an interventional clinical trial within the last 6 months or plans to participate in an interventional clinical trial within the next 24 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• UC Davis Health System — Sacramento
• University Of Illinois — Chicago
• University of Kentucky Medical Center — Lexington
• Brigham And Women's Hospital — Boston
• Mayo Clinic Rochester — Rochester
• Duke University Medical Center — Durham
• Rothman Orthopaedics Institute — Philadelphia
• UT Health Houston — Houston

Идентификаторы

NCT: NCT07059065 · DSS202303 · DSS202303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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