A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

A Prospective, Multi-Center Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

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.

Study Overview

• Status: Completed
• Conditions: Humerus Pathological Fracture
• Intervention / Treatment: Device: Photodynamic Bone Stabilization System

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna
• Germany
  • Koln, Germany, D-50733
    • St. Vinzenz-Hospital GmbH
  • Minden, Germany, 32429
    • Johannes Wesling Klinikum Minden
  • Wetzlar, Germany, 35578
    • Lahn-Dill Kliniken
• Netherlands
  • Enschede, Netherlands, 7513 ER
    • Medisch Spectrum Twente
  • Leeuwarden, Netherlands, 8934 AD
    • Medical Center Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-General Inclusion Criteria

1. Skeletally mature adult males and females 18 years of age or older.
2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.

3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:

   1. Postmenopausal for at least 1 year OR
   2. Documented oophorectomy or hysterectomy
   3. Surgically sterile OR
   4. 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
4. Able to understand and provide informed consent.

5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.

   -Impending Fracture-Specific Inclusion Criteria

6. Documented presence of solitary metastatic lesion.
7. Mirels Criteria Score ≥ 8.

8. Destruction of cortical bone at impending fracture site > 50%.

   -Actual Fracture-Specific Inclusion Criteria

9. 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.
10. Fracture is closed, Gustilo Type I or IIA.

Exclusion Criteria:

-General Exclusion Criteria

1. Primary tumor (osteogenic origin, etc.) at site.
2. Impending fracture or actual fracture location other than humerus.
3. Current concomitant traumatic fracture of any other location.
4. Active or incompletely treated infections that could involve the device implant site.
5. Distant foci of infection that may spread to the implant site.
6. Allergy to implant materials or dental glue.
7. Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.

8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).

   -Impending Fracture-Specific Exclusion Criteria

9. Mirels Score < 8.
10. Destruction of cortical bone at impending fracture site < 50%.
11. Prior surgery and/or prior fracture of affected site.

12. Any articular component to impending fracture site.

    -Actual Fracture-Specific Exclusion Criteria

13. Index treatment is greater than 28 days post fracture.
14. Open fractures with severe contamination.
15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
16. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
17. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 impending and actual pathological fractures of the humerus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Reduction (VAS Pain Score change of > -33% compared to baseline)	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)	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)	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)	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
Disability status	Determined per Investigator assessment	90, 180, 360 days
Evaluation of duration of physical therapy prescription		90, 180, 360 days
Assessment of prescription and over-the-counter analgesic medication use		90, 180, 360 days
Survivability from time of index procedure to death		90, 180, 360 days
Incidence and number of AEs		90, 180, 360 days
Incidence and number of procedure- and device-related complications		90, 180, 360 days
Activities of Daily Living score through all follow-up intervals	Barthel Index of Activities of Daily Living (ADLs), EORTC QLQ-C30 and EORTC QLQ-BM22	90, 180, 360 days
VAS Pain score from baseline through all follow-up intervals	VAS pain scale	90, 180, 360 days

Collaborators and Investigators

• Sponsor: IlluminOss Medical, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Fractures, Bone; Bone Diseases; Fractures, Spontaneous
• Other Study ID Numbers: 14-03-PATHOLHUM-01; NL49653.072.14 (Other Identifier: Institutional Review Board Nijmegen)