Health TrialsbyHealthPanel

Device Global Registry for the IlluminOss Bone Stabilization System

ConditionsTraumatic FracturePathological Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorIlluminOss Medical, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial population

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. The device will be used in a manner consistent with the treating physician's regular clinical practice.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • IlluminOss Device

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Composite Safety Success Rate

Time frame
12 Months

Secondary outcomes

1

Complications/Adverse Events

Time frame
12 Months
2

Successful Device Implantation

Time frame
12 Months
3

Fracture Healing

Time frame
12 Months
4

Disability & Return to Work Status

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IlluminOss Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
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