Safety and Efficacy Study of the Treatment of Humerus Fractures

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02394080
• Date of registration: 16/03/2015
• Prospective Registration: No
• Primary sponsor: IlluminOss Medical, Inc.
• Public title: Safety and Efficacy Study of the Treatment of Humerus Fractures
• Scientific title: CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
• Date of first enrolment: February 2015
• Target sample size: 44
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02394080
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany, Netherlands

Key inclusion & 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Humerus Fractures

Intervention(s)

Device: Photodynamic Bone Stabilization System

Primary Outcome(s)

Normal radiographic fracture healing [Time Frame: 180 days]

Secondary Outcome(s)

Evaluation of complete radiographic healing [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 the procedure- and device-related complication rate [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]

Assessment of disability status [Time Frame: 180 and 360 days]

Assessment of return to work 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]

Assessment of range of motion [Time Frame: 180 and 360 days]

Assessment of return to pre-fracture mobility status [Time Frame: 180 and 360 days]

Assessment of no pain at palpation status [Time Frame: 180 and 360 days]

Assessment of the incidence of adverse events [Time Frame: 180 and 360 days]

Evaluation of normal radiographic healing [Time Frame: 360 days]

Secondary ID(s)

12-03-EUHUM-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors