NCT02394080

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

March 16, 2015

Last Update Submit

June 6, 2017

Conditions

Acute Humerus Fractures

Outcome Measures

Primary Outcomes (1)

  • Normal radiographic fracture healing

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

    180 days

Secondary Outcomes (12)

  • 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

    180 and 360 days

  • Evaluation of normal radiographic healing

    360 days

  • Assessment of no pain at palpation status

    180 and 360 days

  • +7 more secondary outcomes

Study Arms (1)

Photodynamic Bone Stabilization System (PBSS)

EXPERIMENTAL

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

Interventions

Photodynamic Bone Stabilization SystemDEVICE

Treatment of acute humerus fractures

Photodynamic Bone Stabilization System (PBSS)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Amphia Hospital

Breda, 4818 CK, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, 3318 AT, Netherlands

Location

University Hospital Maastricht

Maastricht, 6229 HX, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2017

Study Completion

January 1, 2018

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

NL(3)