Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 6 for:    illuminoss

Safety and Efficacy Study of the Treatment of Humerus Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394080
Recruitment Status : Unknown
Verified June 2017 by IlluminOss Medical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2015
First Posted Date  ICMJE March 20, 2015
Last Update Posted Date June 7, 2017
Study Start Date  ICMJE February 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Safety and Efficacy Study of the Treatment of Humerus Fractures
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Humerus Fractures
Intervention  ICMJE Device: Photodynamic Bone Stabilization System
Treatment of acute humerus fractures
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
44
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2015)
45
Estimated Study Completion Date  ICMJE January 2018
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02394080
Other Study ID Numbers  ICMJE 12-03-EUHUM-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party IlluminOss Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IlluminOss Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IlluminOss Medical, Inc.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP