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

NCT02373904 | Terminated Results

• 2 other identifiers: 14-03-PATHOLHUM-01NL49653.072.14
• Study Type: interventional
• Target: 14
• Locations: 3 countries
• Sites: 6

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.

Conditions

Humerus Pathological Fracture

Outcome Measures

Primary Outcomes (2)

• Pain Reduction

  VAS Pain Score change of \> -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score.

  90 days

• Functional Improvement - Barthel Index

  Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome.

  90 days

Secondary Outcomes (9)

• Pain Reduction

  180 and 360 days

• Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score

  90, 180, 360 days

• Functional Improvement - Barthel Index

  180 and 360 days

• Change From Baseline of Barthel Index of Activities of Daily Living

  90, 180, 360 Days

• Functional Improvement - EORTC QLQ-C30

  90, 180, 360 days

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 System DEVICE

Treatment of impending and actual pathological fractures of the humerus

Photodynamic Bone Stabilization System (PBSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• IlluminOss Medical, Inc.: lead

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

Limitations and Caveats

This study terminated early with 14 out of the projected 45 subjects entered. Study 14-03-PATHOLHUM-02 has full safety endpoints and were used for this study.

Results Point of Contact

• Title: Gene DiPoto
• Organization: IlluminOss Medical Inc.

gdipoto@illuminoss.com

401-714-0008

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-05

Locations

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