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.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Humerus Fractures	Device: Photodynamic Bone Stabilization System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures
• Study Start Date: February 2015
• Actual Primary Completion Date: May 2017
• Estimated Study Completion Date: January 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Normal radiographic fracture healing [ Time Frame: 180 days ]
   Two of four cortices or two of four views demonstrating bridging on standard radiographs

Secondary Outcome Measures :

1. Assessment of the incidence of adverse events [ Time Frame: 180 and 360 days ]
2. Assessment of the procedure- and device-related complication rate [ Time Frame: 180 and 360 days ]
3. 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
4. Evaluation of normal radiographic healing [ Time Frame: 360 days ]
   Two of four cortices or two of four views demonstrating bridging on standard radiographs
5. Assessment of no pain at palpation status [ Time Frame: 180 and 360 days ]
   Clinical assessment
6. Assessment of return to pre-fracture mobility status [ Time Frame: 180 and 360 days ]
   Clinical assessment
7. Comparison of pain visual analog score (VAS) from baseline to all follow up intervals [ Time Frame: 180 and 360 days ]
8. Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals [ Time Frame: 180 and 360 days ]
9. Comparison of Constant shoulder score from baseline to all follow up intervals [ Time Frame: 180 and 360 days ]
10. Assessment of range of motion [ Time Frame: 180 and 360 days ]
    Clinical assessment
11. Assessment of disability status [ Time Frame: 180 and 360 days ]
    Per Investigator assessment
12. Assessment of return to work status [ Time Frame: 180 and 360 days ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Netherlands

Amphia Hospital

Breda, Netherlands, 4818 CK

Albert Schweitzer Hospital

Dordrecht, Netherlands, 3318 AT

University Hospital Maastricht

Maastricht, Netherlands, 6229 HX

Sponsors and Collaborators

IlluminOss Medical, Inc.

More Information

• Responsible Party: IlluminOss Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02394080
• Obsolete Identifiers: NCT02524314
• Other Study ID Numbers: 12-03-EUHUM-01
• First Posted: March 20, 2015
• Last Update Posted: June 7, 2017
• Last Verified: June 2017

Additional relevant MeSH terms:

Fractures, Bone; Humeral Fractures; Wounds and Injuries; Arm Injuries