Clinical trial NCT02394080: Safety and Efficacy Study of the Treatment of Humerus Fractures
Official title: CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Humerus Fractures
Lead sponsor: IlluminOss Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Normal radiographic fracture healing
timeFrame: 180 days
Secondary outcomes:
measure: Assessment of the incidence of adverse events
timeFrame: 180 and 360 days
measure: Assessment of the procedure- and device-related complication rate
timeFrame: 180 and 360 days
measure: Evaluation of complete radiographic healing
timeFrame: 180 and 360 days
measure: Evaluation of normal radiographic healing
timeFrame: 360 days
measure: Assessment of no pain at palpation status
timeFrame: 180 and 360 days
measure: Assessment of return to pre-fracture mobility status
timeFrame: 180 and 360 days
measure: Comparison of pain visual analog score (VAS) from baseline to all follow up intervals
timeFrame: 180 and 360 days
measure: Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals
timeFrame: 180 and 360 days
measure: Comparison of Constant shoulder score from baseline to all follow up intervals
timeFrame: 180 and 360 days
measure: Assessment of range of motion
timeFrame: 180 and 360 days
measure: Assessment of disability status
timeFrame: 180 and 360 days
measure: Assessment of return to work status
timeFrame: 180 and 360 days
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
References: