Humerus Pathological FractureNCT02373904

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

A study testing Photodynamic Bone Stabilization System in people with Humerus Pathological Fracture, run by IlluminOss Medical, Inc. at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Humerus Pathological Fracture
What is being tested?: Photodynamic Bone Stabilization System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 6 sitesin 3 countries
Study dates: Feb 2015to Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

-General Inclusion Criteria
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

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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.
-Impending Fracture-Specific Inclusion Criteria
Documented presence of solitary metastatic lesion.
Mirels Criteria Score ≥ 8.
Destruction of cortical bone at impending fracture site > 50%.
-Actual Fracture-Specific Inclusion Criteria
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.

Who cannot join

-General Exclusion Criteria
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.

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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).
-Impending Fracture-Specific Exclusion Criteria
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.
-Actual Fracture-Specific Exclusion Criteria
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.
Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

Germany3 sites

St. Vinzenz-Hospital GmbH
Cologne, D-50733
Johannes Wesling Klinikum Minden
Minden, 32429
Lahn-Dill Kliniken
Wetzlar, 35578

Other trials in Germany

Netherlands2 sites

Medisch Spectrum Twente
Enschede, 7513 ER
Medical Center Leeuwarden
Leeuwarden, 8934 AD

Other trials in Netherlands

Austria1 site

Medical University of Vienna
Vienna, 1090

Other trials in Austria

About this study

Official title: 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

Conditions: Humerus Pathological Fracture
Being tested: Photodynamic Bone Stabilization System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Photodynamic Bone Stabilization SystemDevice
Treatment of impending and actual pathological fractures of the humerus

Study groups in NCT02373904
Study group	Role	What they receive
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. Receives: Device: Photodynamic Bone Stabilization System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 90 days

Secondary outcomes (9)

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.
Measured: 180 and 360 days
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
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.
Measured: 90, 180, 360 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.
Measured: 180 and 360 days
Change From Baseline of Barthel Index of Activities of Daily Living
Change from baseline in Barthel Index of Activities of Daily Living Score by visit. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Measured: 90, 180, 360 Days
Functional Improvement - EORTC QLQ-C30
Functional Improvement using EORTC QLQ-C30 improvement of >= +10% from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Measured: 90, 180, 360 days
Functional Improvement - EORTC QLQ-BM22
Functional Improvement - EORTC QLQ-BM22 >= 10% change from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Measured: 90, 180, 360 days
Surgical Interventions
Surgical interventions include revisions, supplements, fixations and removals
Measured: 90, 180, 360 days
Device Status
Summary of device status (intact and in-place)
Measured: 90, 180, 360 days
Serious Device-Related Complications
Summary of serious device-related complications
Measured: 90, 180, 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jun 2017

First posted27 Feb 2015 (estimated)
Study startFeb 2015
Primary completionDec 2016
Study completionJun 2017

Why it stopped: Terminated EU portion of trial and utilized US interim analysis data to support marketing application instead. Closure was not due to safety concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Humerus Pathological FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02373904
Sponsor's protocol ID: 14-03-PATHOLHUM-01
Other IDs: NL49653.072.14
Status last verified: May 2026
First submitted: 17 Feb 2015
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Humerus Pathological Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02373904
Acronym / sponsor ID: 14-03-PATHOLHUM-01
Conditions: Humerus Pathological Fracture
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated EU portion of trial and utilized US interim analysis data to support marketing application instead. Closure was not due to safety concerns.
Enrolment: 14 participants (actual)
Lead sponsor: IlluminOss Medical, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Dec 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 27 Feb 2015 (estimated)
Results: Posted 15 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Photodynamic Bone Stabilization System (PBSS)	Experimental	Device: Photodynamic Bone Stabilization SystemThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

-General Inclusion Criteria
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:
Able to understand and provide informed consent.

Key exclusion criteria (20 listed)

-General Exclusion Criteria
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Photodynamic Bone Stabilization SystemTreatment of impending and actual pathological fractures of the humerus	Device	Photodynamic Bone Stabilization System (PBSS)

Primary outcome

Pain Reduction
Time frame: 90 days
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.
Functional Improvement - Barthel Index
Time frame: 90 days
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.

9 secondary outcomes

Pain Reduction
Time frame: 180 and 360 days
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
Time frame: 90, 180, 360 days
Functional Improvement - Barthel Index
Time frame: 180 and 360 days
Change From Baseline of Barthel Index of Activities of Daily Living
Time frame: 90, 180, 360 Days
Functional Improvement - EORTC QLQ-C30
Time frame: 90, 180, 360 days
Functional Improvement - EORTC QLQ-BM22
Time frame: 90, 180, 360 days
Surgical Interventions
Time frame: 90, 180, 360 days
Device Status
Time frame: 90, 180, 360 days
Serious Device-Related Complications
Time frame: 90, 180, 360 days

Results and safety

Results posted to the registry on 15 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Photodynamic Bone Stabilization System (PBSS)	14	7

Primary outcome: Pain Reduction

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Photodynamic Bone Stabilization System (PBSS) n = 5
>= -33% Change	5
<-33% Change	0

Population analysed: Intent-to-Treat (ITT) Population. Subjects who had visit data.

Primary outcome: Functional Improvement - Barthel Index

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Photodynamic Bone Stabilization System (PBSS) n = 4
>= 10% Change	1
<10% Change	3

Population analysed: Intent-to-Treat Population. Subjects who had visit data.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Photodynamic Bone Stabilization System (PBSS)	10 of 14 (71.4%)	4 of 14 (28.6%)	6 of 14

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Humerus Pathological Fracture

Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Active, not recruitingObservational study
Database Retrieval for the Comprehensive Shoulder
Osteoarthritis of the Shoulder, Avascular Necrosis
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
Enrolling by invitationObservational study
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The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Photodynamic Bone Stabilization System in people with Humerus Pathological Fracture, run by IlluminOss Medical, Inc. at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Netherlands, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Reduction (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02373904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.