Device Global Registry for the IlluminOss Bone Stabilization System

Официальное название

IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device

Обзор

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.

Подробное описание

This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months.

Вмешательства

• Устройство IlluminOss Device
  Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.

Первичные конечные точки

• Composite Safety Success Rate [Срок оценки: 12 Months]

Вторичные конечные точки (8)

• Complications/Adverse Events [Срок оценки: 12 Months]
• Successful Device Implantation [Срок оценки: 12 Months]
• Fracture Healing [Срок оценки: 12 Months]
• Disability & Return to Work Status [Срок оценки: 12 Months]
• Discharge Status [Срок оценки: 12 Months]
• Visual Analog Pain Score [Срок оценки: 12 Months]
• Veterans Rand 12 Item Health Survey [Срок оценки: 12 Months]
• Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• Patient has been deemed a candidate for the IlluminOss device
• Patient is male or non-pregnant female
• Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
• Patient is willing and able to give informed consent if required
• Traumatic patient is over the age of 50
• IlluminOss procedure is the initial procedure to treat the traumatic injury

Критерии исключения

United States (U.S.)

This product is contraindicated in U.S. patients who have:

• an active or incompletely treated infection that could involve the site where the device will be implanted;
• are allergic to any of the implant materials or to dental glue;
• have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
• distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
• or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.

European Union (EU)

This product is contraindicated in EU patients who have:

For all Bones:

• Patients who are considered skeletally immature.
• Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
• Patients allergic to any of the implant materials, or to dental glue.
• Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
• Uncooperative patient or patient with neurologic disorder, incapable of following directions.
• Distant foci of infections which may spread to the implant site.
• Vascular insufficiency.
• Open fractures with severe contamination.
• Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
• Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.

For acute Humerus fractures:

• Patients who are under the age of Fifty (50)

For all bones excluding pathologic Humerus:

• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 13 центров

• Gulf Orthopedics — Mobile
• Cedars-Sinai Medical Center — Los Angeles
• Presbyterian St Luke's Medical Ctr — Denver
• University of Miami Hospital — Miami
• Weston Outpatient Surgical Center — Weston
• Parkview Health — Fort Wayne
• Jacobi Medical Center — The Bronx
• Mission Hospital — Asheville
• … и ещё 5 центров

Германия · 3 центра

• St Vinzenz Hospital — Cologne
• Johannes Wesling Hospital Minden — Minden
• Petrus Hospital — Wuppertal

Идентификаторы

NCT: NCT05206981 · REP-2012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗