CompletedNot Applicable

Safety and Efficacy Study of the Treatment of Humerus Fractures

Germany, Netherlands44 participantsStarted 2015-02

Plain-language summary

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 (The Netherlands); AO Classification 11A1, 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2 and 13A1, 13A2 and 13B1, 13B2 (Germany).
. Fracture is closed, Gustilo Type I or II.
. Skeletally mature men and women, 50 years of age or older (The Netherlands only) or 61 years of age or older (Germany only) at time of index injury.
. a) Female patients of child bearing potential agree to use double barrier method of contraception (The Netherlands only) b) Female patients of non-child bearing potential must meet one of the following criteria (The Netherlands only):
. Willing and able to understand and sign the informed consent.

Exclusion criteria

. Index treatment is greater than 28 days (The Netherlands only) or 14 days (Germany only) post fracture
. Open fractures with severe contamination.
. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
. Marked bone loss or bone resorption patients, who due to a prior delayed union or non-union of the bones or other illnesses, may not be able to have their fracture adequately reduced prior to placement of the IlluminOss-device. This could leave bone void spaces that would preclude the device from maintaining alignment of the fractured bone.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Normal Radiographic Fracture Healing

Timeframe: 180 days

Trial details

NCT IDNCT02394080

SponsorIlluminOss Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

Results submitted2018-01-15

View on ClinicalTrials.gov More Acute Humerus Fractures trials