Humerus Fracture Metastatic Bone DiseaseNCT02338492

Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

A study testing Photodynamic Bone Stabilization System in people with Humerus Fracture Metastatic Bone Disease, run by IlluminOss Medical, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of 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 Fracture Metastatic Bone Disease
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: 81 participants
Where: 13 sitesUnited States
Study dates: Mar 2015to Jul 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
Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
VAS Pain Score > 60mm on 100mm scale.
-Impending Fracture-Specific Inclusion Criteria
Documented presence of at least one metastatic lesion of the humerus.
Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements)
Destruction of cortical bone at impending fracture site > 50%.
-Actual Fracture-Specific Inclusion Criteria
Fracture is closed, Gustilo Type I or II.

Who cannot join

General Exclusion Criteria
Primary tumor (osteogenic origin, etc.) at site.
Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
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.

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In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
Prisoner
-Impending Fracture-Specific Exclusion Criteria
Mirels Score < 8 (specific to target humeral lesion).
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
Open fractures with severe contamination.
Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Emory University School of Medicine
Atlanta, Georgia, 30329
MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Duke University School of Medicine
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Marshall University
Huntington, West Virginia, 25701
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Pittsburgh Physicians
Pittsburgh, Pennsylvania, 15232
University Orthopedics Inc.
Providence, Rhode Island, 02905
Stanford School of Medicine
Redwood City, California, 94063
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

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

This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.

Read the detailed description

This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.

Conditions: Humerus Fracture Metastatic Bone Disease
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 NCT02338492
Study group	Role	What they receive
Photodynamic Bone Stabilization System	Experimental	Photodynamic Bone Stabilization System (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.

Change in Pain
Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).
Measured: Baseline and 90 days
Change in Function
Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Measured: Baseline and 90 days
Summary of Clinical Safety Success
No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation
Measured: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360

Secondary outcomes (8)

Pain at Palpation
Pain on palpation and clinical significance
Measured: 90, 180 and 360 days
Duration of Index Procedure
Duration of index procedure (hours)
Measured: 1 Day
Activities of Daily Living Score Through All Follow-up Intervals
Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.
Measured: Baseline, 90, 180 and 360 days
MSTS Upper Extremity Functional Outcome
Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Measured: 90, 180, 360 days
Assessment of Post-Surgery Status
Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Measured: Surgery & Discharge, 7-14, 30, 90, 180, 360 days
Summary of Procedure and Device-Related Complications Rate
Procedure and device-related complications rate presented at follow-up visits
Measured: up to day 90, up to day180 since day 90, up to 360 since day 180
Summary of Change From Baseline Range of Motion by Visit and Test
Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.
Measured: Baseline, 90, 180 and 360 Days
Length of Hospital Stay
Length of hospital stay (from day of procedure to day of discharge)
Measured: From day of procedure until the day of hospital discharge (up to 36 days)

Timeline

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

Mar 2015Jul 2017

First posted14 Jan 2015 (estimated)
Study startMar 2015
Primary completionOct 2016
Study completionJul 2017

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 Fracture Metastatic Bone DiseaseStudies 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: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02338492
Sponsor's protocol ID: 14-03-PATHOLHUM-02
Status last verified: Apr 2018
First submitted: 7 Jan 2015
Last updated: 17 May 2018
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2018. 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: NCT02338492
Acronym / sponsor ID: 14-03-PATHOLHUM-02
Conditions: Humerus Fracture Metastatic Bone Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: IlluminOss Medical, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Oct 2016 (actual)
Study completion: Jul 2017 (actual)
First posted: 14 Jan 2015 (estimated)
Results: Posted 17 May 2018

Clinical summary

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

This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.

Detailed description

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	Experimental	Device: Photodynamic Bone Stabilization SystemPhotodynamic Bone Stabilization System (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:
Patient, or his/her legally authorized representative, is able to understand and provide informed consent.

Key exclusion criteria (19 listed)

General Exclusion Criteria
Primary tumor (osteogenic origin, etc.) at site.
Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
Active or incompletely treated infections that could involve the device implant site.
Distant foci of infection that may spread to the 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

Primary outcome

Change in Pain
Time frame: Baseline and 90 days
Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).
Change in Function
Time frame: Baseline and 90 days
Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Summary of Clinical Safety Success
Time frame: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360
No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation

8 secondary outcomes

Pain at Palpation
Time frame: 90, 180 and 360 days
Duration of Index Procedure
Time frame: 1 Day
Activities of Daily Living Score Through All Follow-up Intervals
Time frame: Baseline, 90, 180 and 360 days
MSTS Upper Extremity Functional Outcome
Time frame: 90, 180, 360 days
Assessment of Post-Surgery Status
Time frame: Surgery & Discharge, 7-14, 30, 90, 180, 360 days
Summary of Procedure and Device-Related Complications Rate
Time frame: up to day 90, up to day180 since day 90, up to 360 since day 180
Summary of Change From Baseline Range of Motion by Visit and Test
Time frame: Baseline, 90, 180 and 360 Days
Length of Hospital Stay
Time frame: From day of procedure until the day of hospital discharge (up to 36 days)

Results and safety

Results posted to the registry on 17 May 2018, 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)	81	36

Primary outcome: Change in Pain

Time frame: Baseline and 90 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	Photodynamic Bone Stabilization System (PBSS) n = 56
Value	-52.7 (3.62)

Photodynamic Bone Stabilization System (PBSS): p = 0.615, Mixed Models Analysis

Population analysed: Number of subjects who had a Day 90 visit

Primary outcome: Change in Function

Time frame: Baseline and 90 days. Least squares mean (Standard Error). Unit: units on a scale

Measure	Photodynamic Bone Stabilization System (PBSS) n = 52
Value	39.23 (2.929)

Population analysed: Subjects who had 90 Day data

Primary outcome: Summary of Clinical Safety Success

Time frame: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360. Count of participants. Unit: Participants

Measure	Photodynamic Bone Stabilization System (PBSS) n = 81
Up to D7-14 : No serious dev rel complications	81
Up to D7-14 : No additional surgical intervention	81
Up to D7-14 : No device fracture, migration	80
Up to D7-14 : Safety Success	80
Up to D30 : No serious dev rel complications	80
Up to D30 : No additional surgical intervention	80
Up to D30 : No device fracture, migration	78
Up to D30 : Safety Success	78

Photodynamic Bone Stabilization System (PBSS): Percentage of Subjects: 100.0 (95% CI 96 to 100)
Photodynamic Bone Stabilization System (PBSS): Percentage of Subjects: 100 (95% CI 96 to 100)
Photodynamic Bone Stabilization System (PBSS): Percentage of Subjects: 98.8 (95% CI 93 to 100)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Photodynamic Bone Stabilization System (PBSS)	58 of 81 (71.6%)	49 of 81 (60.5%)	32 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

13 sites in 1 country: 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 Fracture Metastatic Bone Disease, run by IlluminOss Medical, Inc. at 13 sites in United States.

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 19 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: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 17 May 2018). 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?

Change in Pain (time frame: Baseline and 90 days). The study lists 3 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 NCT02338492.

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 17 May 2018.