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Recruiting NCT05206981

Device Global Registry for the IlluminOss Bone Stabilization System

— Observational Traumatic Fracture Pathological Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IlluminOss Device.
Who it may be relevant to
Registry conditions: Traumatic Fracture, Pathological Fracture. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Composite Safety Success Rate [Time frame: 12 Months]
Secondary outcome measures (8)
  • Complications/Adverse Events [Time frame: 12 Months]
  • Successful Device Implantation [Time frame: 12 Months]
  • Fracture Healing [Time frame: 12 Months]
  • Disability & Return to Work Status [Time frame: 12 Months]
  • Discharge Status [Time frame: 12 Months]
  • Visual Analog Pain Score [Time frame: 12 Months]
  • Veterans Rand 12 Item Health Survey [Time frame: 12 Months]
  • Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function [Time frame: 12 Months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 13 centers
  • 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
  • … and 5 more centers
Germany · 3 centers
  • St Vinzenz Hospital — Cologne
  • Johannes Wesling Hospital Minden — Minden
  • Petrus Hospital — Wuppertal

Identifiers

NCT: NCT05206981 · REP-2012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗