Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device

Официальное название

The Stability Study: Open-Label, Multi-Center, Post-Market Study of Functional Motion Outcomes In Subjects Treated With the Spinal Simplicity Minuteman G5 Fusion Plate

Обзор

This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.

Подробное описание

Up to 150 subjects will be enrolled and treated at up to 20 study sites. Qualified subjects will be enrolled and treated with the Minuteman G5 Device. Subjects will be seen at 1-, 3-, 6- and 12-months following study treatment.

Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion.

After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.

Вмешательства

• Устройство Minuteman G5 Device
  The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

Первичные конечные точки

• Pain (Overall, Back and Leg) using NRS/numeric rating scale [Срок оценки: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.]
• Oswestry Disability Index (ODI) [Срок оценки: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.]
• PROMIS 29 2.0 [Срок оценки: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.]
• Assessment of Motion using BioMech Lab testing equipment [Срок оценки: Baseline and 1-, 3- and 12-months post implantation.]
• Zurich Classification Questionnaire (ZCQ) [Срок оценки: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.]

Вторичные конечные точки (1)

• Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan [Срок оценки: Collected at 12 months post implantation.]

Критерии участия

Критерии включения

A subject must MEET ALL of the following inclusion criteria:

• Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
• Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided
• Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
• Be 18 years of age or older at the time of enrollment
• Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
• Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
• Be willing and able to comply with study-related requirements, procedures and visits
• Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
• Must disclose any unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the Investigator. Including being involved in an injury claim under current litigation or has a pending or approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.

Критерии исключения

A subject must NOT MEET ANY of the following exclusion criteria:

• Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
• Patient physically unable to perform the Gait and/or Balance tests.
• Current systemic infection or local infection increasing the risk of surgery
• History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
• Grade II-V spondylolisthesis
• Significant scoliosis with Cobb angle >10 degrees
• Unremitting back pain in a spinal flexion position
• Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
• Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
• Vertebral osteoporosis or history of vertebral fracture
• Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
• Malformation or dysplasia of spinous process
• Severe osteoporosis with T score <-2.5 SD

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Vista Clinical Research — Newnan
• Comprehensive Pain & Spine Specialists — Indianapolis
• University of Kansas Medical Center — Kansas City
• Nura Precision Pain Management — Edina
• Pacific Sports & Spine — Eugene
• Spine & Nerve Center of the Virginias — Charleston

Идентификаторы

NCT: NCT06355791 · PDPROJ-4-TP-001-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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