Идёт набор NCT06462729

LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Фаза I / Фаза II С лечением Degenerative Disc Disease Lumbar Disc Disease Spine Disease Lumbar Spine Degeneration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LDGraft, LDGraft, Allograft Bone.
Кому может быть актуально: Состояния в реестре: Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration. Базовые параметры: 22 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)

Обзор

The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease (DDD).

Подробное описание

This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure. This is a first in human (FIH) study.

The study will enroll patients with lumbar degenerative disc disease (DDD) requiring single level ALIF. The procedure will involve use of an intervertebral cage and fixation (plate and screws).

Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 3:3:2 to the LDGraft groups (investigational) or the allograft control group. Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion.

Вмешательства

Устройство LDGraft
LDGraft 0.5mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Устройство LDGraft
LDGraft 1.0mg/cc rhBMP-2 applied within intervertebral cage with placement of anterior fixation (plate and screws)
Другое Allograft Bone
Allograft bone (100% human tissue product) applied within intervertebral cage with placement of anterior fixation (plate and screws)

Первичные конечные точки

Radiographic Fusion [Срок оценки: 12 months and 24 months]
Secondary Surgical Intervention [Срок оценки: 12 months and 24 months]
Oswestry Disability Index (ODI) Score [Срок оценки: 12 months and 24 months]
Neurological Condition [Срок оценки: 12 months and 24 months]
Serious Device-Related Adverse Events [Срок оценки: 12 months and 24 months]

Вторичные конечные точки (7)

Radiographic Outcomes [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Visual Analog Score (VAS) Back [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Visual Analog Score (VAS) Change Back [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Visual Analog Score (VAS) Leg [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Visual Analog Score (VAS) Change Leg [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Oswestry Disability Index (ODI) Score [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]
Oswestry Disability Index (ODI) Change [Срок оценки: 6 weeks, 3 months, 6 months, 12 months and 24 months]

Критерии участия

Критерии включения

Skeletally mature adults ≥22 and ≤80 years at the time of surgery
Willing and able to give written informed consent and comply with study protocol and postoperative management program
Degenerative disc disease of the lumbosacral spine in one level (L3 to S1) requiring fusion confirmed by patient history and radiographic imaging (CT/MRI/X-rays) with one or more of the following:

instability (as defined by ≥3mm translation or ≥5° angulation);
osteophyte formation of facet joints or vertebral endplates;
decreased disc height, on average by >2mm, but dependent upon the spinal level;
scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
herniated nucleus pulposus;
facet joint degeneration/changes; and/or
vacuum phenomenon.
Preoperative Oswestry Disability Index score ≥ 35
Participant has not responded to conservative treatment (e.g. medications, injections, physical therapy, etc.) for a period of 6 months
Participant is indicated for an ALIF approach to the lumbar spine

Критерии исключения

Previous lumbar spine instrumentation (i.e., anterior disc replacement, interspinous device) or a previous interbody fusion procedure in the lumbar spine
More than one level lumbar spine level requiring fusion
Three or more contiguous lumbar spine levels requiring decompression (Note: Up to two contiguous levels of decompression is acceptable)
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.
Pregnant, planning to become pregnant during the follow-up time period, or breast-feeding women
Presence of active malignancy
Requires bone growth stimulation in the lumbar spine
Active local or systemic infection
Spondylolisthesis greater than Grade 1 (25% translation)
Currently smoking or using nicotine products, including e-cigarette products (e.g., vaping) (Use within 30 days of screening date is considered 'current')
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
Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) or receiving radiation therapy that is expected to continue for the duration of the study
Body Mass Index > 35
Insulin-dependent diabetes mellitus
Osteopenia or osteoporosis of the spine, DEXA T score of ≤ -1.0
Any secondary causes of osteoporosis (e.g. chronic liver or kidney disease, uncontrolled hyper- or hypothyroidism, type I or type II diabetes mellitus, gastrointestinal malabsorption syndromes) or other conditions known to adversely affect osteogenesis (e.g. Paget's disease, Ehlers-Danlos syndrome or osteogenesis imperfecta)
Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs;
Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 (Diagnostic and Statistical Manual) code
In the opinion of the investigator, the participant has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the product
Radiographically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, deformity, malunion or nonunion
Currently a prisoner
Involved in active litigation relating to his/her spinal condition or workers compensation claimants.