Safety and Efficacy Study of the Treatment of Humerus Fractures

IlluminOss Medical

Status: Unknown

Conditions: Acute Humerus Fractures

Treatments: Device: Photodynamic Bone Stabilization System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02394080

12-03-EUHUM-01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Fracture-Specific Inclusion Criteria

1. 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.

2. Fracture is closed, Gustilo Type I or II.

   General Inclusion Criteria

3. Skeletally mature men and women, 50 years of age or older at time of index injury.

4. a) Female patients of child bearing potential agree to use double barrier method of contraception b) Female patients of non-child bearing potential must meet one of the following criteria:

   • Postmenopausal for at least 1 year, or
   • Documented oophorectomy or hysterectomy, or
   • Surgically sterile

5. Willing and able to understand and sign the informed consent.

Fracture-Specific Exclusion Criteria

1. Index treatment is greater than 28 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. Pregnant or lactating.

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 (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).

15. Life expectancy less than one year due to concurrent illness.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Photodynamic Bone Stabilization System (PBSS)

Experimental group

Description:

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.

Treatment:

Device: Photodynamic Bone Stabilization System