Safety and Efficacy Study of the Treatment of Humerus Fractures

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Humerus Fractures
• Intervention / Treatment: Device: Photodynamic Bone Stabilization System

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Hospital
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Hospital
  • Maastricht, Netherlands, 6229 HX
    • University Hospital Maastricht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photodynamic Bone Stabilization System (PBSS); 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.	Device: Photodynamic Bone Stabilization System; Treatment of acute humerus fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal radiographic fracture healing	Two of four cortices or two of four views demonstrating bridging on standard radiographs	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the incidence of adverse events		180 and 360 days
Assessment of the procedure- and device-related complication rate		180 and 360 days
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
Evaluation of normal radiographic healing	Two of four cortices or two of four views demonstrating bridging on standard radiographs	360 days
Assessment of no pain at palpation status	Clinical assessment	180 and 360 days
Assessment of return to pre-fracture mobility status	Clinical assessment	180 and 360 days
Comparison of pain visual analog score (VAS) from baseline to all follow up intervals		180 and 360 days
Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals		180 and 360 days
Comparison of Constant shoulder score from baseline to all follow up intervals		180 and 360 days
Assessment of range of motion	Clinical assessment	180 and 360 days
Assessment of disability status	Per Investigator assessment	180 and 360 days
Assessment of return to work status		180 and 360 days

Collaborators and Investigators

• Sponsor: IlluminOss Medical, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: 12-03-EUHUM-01