Overview

This trial is active, not recruiting.

Condition acute humerus fractures
Treatment photodynamic bone stabilization system
Sponsor IlluminOss Medical, Inc.
Start date August 2015
End date May 2017
Trial size 44 participants
Trial identifier NCT02524314, 12-03-EUHUM-01 Germany, 2012353

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone.
photodynamic bone stabilization system
Treatment of acute humerus fractures

Primary Outcomes

Measure
Normal radiographic fracture healing
time frame: 180 days

Secondary Outcomes

Measure
Assessment of the incidence of adverse events
time frame: 180 and 360 days
Assessment of the procedure- and device-related complication rate
time frame: 180 and 360 days
Evaluation of complete radiographic healing
time frame: 180 and 360 days
Evaluation of normal radiographic healing
time frame: 360 days
Assessment of no pain at palpation status
time frame: 180 and 360 days
Assessment of return to pre-fracture mobility status
time frame: 180 and 360 days
Comparison of pain visual analog score (VAS) from baseline to all follow up intervals
time frame: 180 and 360 days
Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals
time frame: 180 and 360 days
Comparison of Constant shoulder score from baseline to all follow up intervals
time frame: 180 and 360 days
Assessment of range of motion
time frame: 180 and 360 days
Assessment of disability status
time frame: 180 and 360 days
Assessment of return to work status
time frame: 180 and 360 days

Eligibility Criteria

Male or female participants at least 61 years old.

Fracture-Specific Inclusion Criteria 1. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2. 2. Fracture is closed, Gustilo Type I or IIA. General Inclusion Criteria 3. Skeletally mature men and women, 61 years of age or older at time of index injury. 4. Willing and able to understand and sign the informed consent. Fracture-Specific Exclusion Criteria 1. Index treatment is greater than 14 days post fracture. 2. Open fractures with severe contamination. 3. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 4. 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. 5. Previous fracture of affected limb. General Exclusion Criteria 6. Contralateral fracture of the forearm or humerus. 7. Active or incompletely treated infections that could involve the site where the device will be implanted. 8. Distant foci of infections that may spread to the implant site. 9. Uncooperative patients or patients who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder). 10. Concomitant metabolic disorders that may impair bone formation. 11. Osteomalacia. 12. Allergic to implant materials or dental glue. 13. Vascular insufficiency, muscular atrophy, or neuro-muscular disease. 14. Polytrauma patients. 15. Life expectancy less than one year due to concurrent illness.

Additional Information

Official title CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by IlluminOss Medical, Inc..