REFLECT Scoliosis System Post Approval Study

Официальное название

A Prospective, Single-Arm, Multi-Center, Registry Post-Approval Study of Growth Modulation in the Treatment of Idiopathic Scoliosis With the REFLECT™ Scoliosis Correction System

Обзор

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval

Подробное описание

The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials. REFLECT™ uses a growth modulation technique in which growth of the patient is used to achieve progressive scoliosis correction.

The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.

A total of 100 patients will be prospectively enrolled and treated at a minimum of 5 U.S. sites, with a maximum of 20 subjects at any one site, with sequential enrollment from each site. Patients will be followed for 5 years with evaluations at the following timepoints: preoperative, intraoperative, immediate postoperative (first erect), 6 weeks, 6 months, 12 months, 24 months, and 60 months. Primary and secondary outcomes from 100 patients enrolled and treated with REFLECT™ will be summarized.

Вмешательства

• Устройство REFLECT Scoliosis Correction System
  The REFLECT™ Scoliosis Correction System is designed for continued growth and mobility of the spine as well as straightening of the spine by holding the segments in a more natural anatomic position using non-rigid materials.

Первичные конечные точки

• Primary Probable Benefit [Срок оценки: 60 months postoperative]
• Primary Safety [Срок оценки: 60 months postoperative]

Вторичные конечные точки (5)

• Curve progression [Срок оценки: 60 months postoperative]
• Device integrity [Срок оценки: 60 months postoperative]
• Composite endpoint analysis [Срок оценки: 60 months postoperative]
• Failure analysis [Срок оценки: 60 months postoperative]
• SRS score [Срок оценки: 60 months postoperative]

Критерии участия

Критерии включения

• Diagnosis of progressive idiopathic scoliosis
• Preoperative major Cobb angle 30°-65°
• Preoperative flexibility to ≤30° on side bending radiograph (left or right)
• Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8
• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
• Failed or intolerant to bracing
• Signed informed consent and/or assent forms specific to this study

Критерии исключения

• Prior spinal surgery at the level(s) to be treated
• Documented poor bone quality, defined as a T-score of -1.5 or less
• Presence of any systemic infection, local infection, or skin compromise at the surgical site
• Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions
• Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
• Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study

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 · 2 центра

• Mayo Clinic — Rochester
• New York University — New York

Идентификаторы

NCT: NCT06298812 · GMED.REF0723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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