Prospective i-FactorTM Analysis Fusion Rate and Quality of Life

Официальное название

Prospective Analysis of the i-FactorTM Bone Graft on the Fusion Rate and Quality of Life of Patients With Adult Spine Deformity

Обзор

Adult spinal deformity surgery is a complex procedure that involves many risks and complications. Bone grafts and bone substitutes are essential to achieve fusion and manage stability in spinal surgery. Autologous bone has been considered the "gold-standard" for obtaining a spinal fusion. However, the source from which to obtain it is limited. Furthermore, the problems of bone quality in patients with osteoporosis and the morbidity have forced the orthopedic community to seek other options. I-Factor ™ Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles. In the literature there are no articles which identify bone formation with the i-Factor ™ graft in more than 4 instrumented levels, therefore the development of this study will allow assessing the fusion rate and quality of life of patients, which could lead to an improvement in the management and decision-making of surgical procedures, as well as better control of healthcare spending

Вмешательства

• Биопрепарат i-FactorTM Bone graft
  In the i-Factor ™ group it will be placed longitudinally in the intertransverse area. Likewise, in both groups, only autologous and bench bone will be placed in the intersomatic cages. The vertebrae where the i-Factor ™ is placed will be noted on the data collection sheet.

Первичные конечные точки

• Fusion rate [Срок оценки: 2 years]
• Minimal Clinically Important Difference (MCID) [Срок оценки: 2 years]
• Short Form Health Survey-12 General Quality of life questionnaire [Срок оценки: 2 years]
• Owestry disability index [Срок оценки: 2 years]
• VISUAL ANALOGUE SCALE [Срок оценки: 2 years]
• Scoliosis Research Society (SRS-22) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Patients of legal age.
• Patients diagnosed with adult deformity, whether due to scoliosis, imbalance, thoracolumbar curves, etc. In which the minimum number of levels to be instrumented is 5, that is, 4 intervertebral discs.
• Patients who provide their informed consent in writing. (In the event that the patient's circumstances do not allow him to grant consent, this may be provided by the legal representative).
• Present radiological tests, computed tomography and / or magnetic resonance imaging prior to surgery.
• The implants used in the surgery are Cobalt Chrome bars and Titanium screws and interbody cages.

Критерии исключения

• Patients who are expected to be unavailable for follow-up.
• Patients with mental disabilities that make it difficult for them to fill in the questionnaires.
• Patients who have had other types of implants placed, other than Cobalt Chrome bars and Titanium screws and interbody cages.
• Patients who are going to have cemented and / or expansive screws, Peek boxes or another type of material other than Titanium.
• Underlying neurological or neuromuscular disease.
• Underlying inflammatory or tumor disease.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• CAULE — León

Идентификаторы

NCT: NCT04610021 · CAULE-IFACTOR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗