Back to resultsSafety and Efficacy Study of the Treatment of Humerus Fractures
Primary Purpose
Acute Humerus Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Photodynamic Bone Stabilization System
Sponsored by
About this trial
This is an interventional treatment trial for Acute Humerus Fractures
Eligibility Criteria
Fracture-Specific Inclusion Criteria
- 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.
Fracture is closed, Gustilo Type I or II.
General Inclusion Criteria
- Skeletally mature men and women, 50 years of age or older at time of index injury.
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
- Willing and able to understand and sign the informed consent.
Fracture-Specific Exclusion Criteria
- Index treatment is greater than 28 days post fracture
- Open fractures with severe contamination.
- Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- 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.
Previous fracture of affected limb.
General Exclusion Criteria
- Pregnant or lactating.
- Active or incompletely treated infections that could involve the site where the device will be implanted.
- Distant foci of infections that may spread to the implant site
- Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder).
- Concomitant metabolic disorders that may impair bone formation.
- Osteomalacia.
- Allergic to implant materials or dental glue.
- Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
- Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).
- Life expectancy less than one year due to concurrent illness.
Sites / Locations
- Amphia Hospital
- Albert Schweitzer Hospital
- University Hospital Maastricht
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photodynamic Bone Stabilization System (PBSS)
Arm Description
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.
Outcomes
Primary Outcome Measures
Normal radiographic fracture healing
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Secondary Outcome Measures
Assessment of the incidence of adverse events
Assessment of the procedure- and device-related complication rate
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
Evaluation of normal radiographic healing
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Assessment of no pain at palpation status
Clinical assessment
Assessment of return to pre-fracture mobility status
Clinical assessment
Comparison of pain visual analog score (VAS) from baseline to all follow up intervals
Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals
Comparison of Constant shoulder score from baseline to all follow up intervals
Assessment of range of motion
Clinical assessment
Assessment of disability status
Per Investigator assessment
Assessment of return to work status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02394080
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlluminOss Medical, Inc.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Humerus Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photodynamic Bone Stabilization System (PBSS)
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Photodynamic Bone Stabilization System
Intervention Description
Treatment of acute humerus fractures
Primary Outcome Measure Information:
Title
Normal radiographic fracture healing
Description
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Assessment of the incidence of adverse events
Time Frame
180 and 360 days
Title
Assessment of the procedure- and device-related complication rate
Time Frame
180 and 360 days
Title
Evaluation of complete radiographic healing
Description
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
Time Frame
180 and 360 days
Title
Evaluation of normal radiographic healing
Description
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Time Frame
360 days
Title
Assessment of no pain at palpation status
Description
Clinical assessment
Time Frame
180 and 360 days
Title
Assessment of return to pre-fracture mobility status
Description
Clinical assessment
Time Frame
180 and 360 days
Title
Comparison of pain visual analog score (VAS) from baseline to all follow up intervals
Time Frame
180 and 360 days
Title
Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals
Time Frame
180 and 360 days
Title
Comparison of Constant shoulder score from baseline to all follow up intervals
Time Frame
180 and 360 days
Title
Assessment of range of motion
Description
Clinical assessment
Time Frame
180 and 360 days
Title
Assessment of disability status
Description
Per Investigator assessment
Time Frame
180 and 360 days
Title
Assessment of return to work status
Time Frame
180 and 360 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Fracture-Specific Inclusion Criteria
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.
Fracture is closed, Gustilo Type I or II.
General Inclusion Criteria
Skeletally mature men and women, 50 years of age or older at time of index injury.
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
Willing and able to understand and sign the informed consent.
Fracture-Specific Exclusion Criteria
Index treatment is greater than 28 days post fracture
Open fractures with severe contamination.
Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
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.
Previous fracture of affected limb.
General Exclusion Criteria
Pregnant or lactating.
Active or incompletely treated infections that could involve the site where the device will be implanted.
Distant foci of infections that may spread to the implant site
Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder).
Concomitant metabolic disorders that may impair bone formation.
Osteomalacia.
Allergic to implant materials or dental glue.
Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident).
Life expectancy less than one year due to concurrent illness.
Facility Information:
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Albert Schweitzer Hospital
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of the Treatment of Humerus Fractures
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