NCT02373904

Brief Summary

The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
3 countries

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

February 17, 2015

Last Update Submit

July 31, 2017

Conditions

Humerus Pathological Fracture

Outcome Measures

Primary Outcomes (4)

  • Pain Reduction

    VAS Pain Score change of \> -33% compared to baseline

    90 days

  • Functional Improvement (Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline)

    * Barthel Index of Activities of Daily Living (ADLs) improvement of \> +10% from baseline * EORTC QLQ-C30 improvement of \> +10% from baseline * EORTC QLQ-BM22 improvement of \> +10% from baseline

    90 days

  • Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)

    * No Serious Device Related Complications * No additional surgical interventions: revisions, supplements, fixations or removals

    90 days

  • Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)

    No device fracture, migrations, mal-alignment or loss of reduction or fixation

    90 days

Secondary Outcomes (13)

  • Pain Reduction (VAS Pain Score change of > -33% compared to baseline)

    90, 180 and 360 days

  • Functional Improvement (-Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline)

    90, 180, 360 days

  • Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals)

    90, 180, 360 days

  • Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation)

    90, 180, 360 days

  • Duration of index procedure and length of hospital stay

    90, 180, 360 days

  • +8 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 impending and actual pathological fractures of the humerus

Photodynamic Bone Stabilization System (PBSS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Skeletally mature adult males and females 18 years of age or older.
  • Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
  • Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:
  • Postmenopausal for at least 1 year OR
  • Documented oophorectomy or hysterectomy
  • Surgically sterile OR
  • If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
  • Able to understand and provide informed consent.
  • Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
  • Documented presence of solitary metastatic lesion.
  • Mirels Criteria Score ≥ 8.
  • Destruction of cortical bone at impending fracture site \> 50%.
  • Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2.
  • Fracture is closed, Gustilo Type I or IIA.

You may not qualify if:

  • Primary tumor (osteogenic origin, etc.) at site.
  • Impending fracture or actual fracture location other than humerus.
  • Current concomitant traumatic fracture of any other location.
  • Active or incompletely treated infections that could involve the device implant site.
  • Distant foci of infection that may spread to the implant site.
  • Allergy to implant materials or dental glue.
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.
  • Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
  • Mirels Score \< 8.
  • Destruction of cortical bone at impending fracture site \< 50%.
  • Prior surgery and/or prior fracture of affected site.
  • Any articular component to impending fracture site.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Medical University of Vienna

Vienna, 1090, Austria

Location

St. Vinzenz-Hospital GmbH

Cologne, D-50733, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Lahn-Dill Kliniken

Wetzlar, 35578, Germany

Location

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, 8934 AD, 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

February 17, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

DE(3)AU(1)NL(2)