Safety and Efficacy Study of the Treatment of Humerus Fractures

Acute Humerus Fractures Clinical Trial

Official title:

CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02394080
• Other study ID #: 12-03-EUHUM-01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: June 6, 2017
• Start date: February 2015
• Est. completion date: January 2018

Study information

• Verified date: June 2017
• Source: IlluminOss Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: January 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Humerus Fractures
• Fractures, Bone
• Humeral Fractures

Intervention

Device:
• Photodynamic Bone Stabilization System
Treatment of acute humerus fractures

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
IlluminOss Medical, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal radiographic fracture healing	Two of four cortices or two of four views demonstrating bridging on standard radiographs	180 days
Secondary	Assessment of the incidence of adverse events		180 and 360 days
Secondary	Assessment of the procedure- and device-related complication rate		180 and 360 days
Secondary	Evaluation of complete radiographic healing	Three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (greater than or equal to 75% on orthogonal views) of fracture lines	180 and 360 days
Secondary	Evaluation of normal radiographic healing	Two of four cortices or two of four views demonstrating bridging on standard radiographs	360 days
Secondary	Assessment of no pain at palpation status	Clinical assessment	180 and 360 days
Secondary	Assessment of return to pre-fracture mobility status	Clinical assessment	180 and 360 days
Secondary	Comparison of pain visual analog score (VAS) from baseline to all follow up intervals		180 and 360 days
Secondary	Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals		180 and 360 days
Secondary	Comparison of Constant shoulder score from baseline to all follow up intervals		180 and 360 days
Secondary	Assessment of range of motion	Clinical assessment	180 and 360 days
Secondary	Assessment of disability status	Per Investigator assessment	180 and 360 days
Secondary	Assessment of return to work status		180 and 360 days