Safety and Efficacy Study of the Treatment of Humerus Fractures

• ClinicalTrials.gov Identifier: NCT02394080
• Recruitment Status: Unknown
• First Posted: March 20, 2015
• Last Update Posted: June 7, 2017
• Sponsor: IlluminOss Medical, Inc.
• Information provided by (Responsible Party): IlluminOss Medical, Inc.

Tracking Information

• First Submitted Date: March 16, 2015
• First Posted Date: March 20, 2015
• Last Update Posted Date: June 7, 2017
• Study Start Date: February 2015
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2015)

Normal radiographic fracture healing [ Time Frame: 180 days ]

Two of four cortices or two of four views demonstrating bridging on standard radiographs

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 20, 2015)

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

Original Secondary Outcome Measures (submitted: March 16, 2015)

• Assessment of the incidence of adverse events [ Time Frame: 180 and 360 days ]
• Assessment of the procedure- and device-related complication rate [ Time Frame: 180 and 360 days ]
• Evaluation of complete radiographic healing [ Time Frame: 180 and 360 days ]
  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
• Evaluation of normal radiographic healing [ Time Frame: 360 days ]
  Two of four cortices or two of four views demonstrating bridging on standard radiographs
• Assessment of no pain at palpation status [ Time Frame: 180 and 360 days ]
• Assessment of return to pre-fracture mobility 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 ]
• Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals [ 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 range of motion [ Time Frame: 180 and 360 days ]
• Assessment of disability status [ Time Frame: 180 and 360 days ]
  Per Investigator assessment
• Assessment of return to work status [ Time Frame: 180 and 360 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Humerus Fractures

Intervention

Device: Photodynamic Bone Stabilization System

Treatment of acute humerus fractures

Study Arms

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.

Intervention: Device: Photodynamic Bone Stabilization System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 1, 2016): 44
• Original Estimated Enrollment (submitted: March 16, 2015): 45
• Estimated Study Completion Date: January 2018
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT02394080
• Other Study ID Numbers: 12-03-EUHUM-01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: IlluminOss Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: IlluminOss Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: IlluminOss Medical, Inc.
• Verification Date: June 2017