Trial Outcomes & Findings for A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease (NCT NCT02373904)
NCT ID: NCT02373904
Last Updated: 2026-07-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
90 days
Results posted on
2026-07-15
Participant Flow
14 were enrolled but only 9 are in the intent-to-treat population. Analysis presented for the 9
Participant milestones
| Measure |
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Subjects who had actual fracture
Baseline characteristics by cohort
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 5.85 • n=9 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=9 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=9 Participants
|
|
Pain (VAS Score)
|
58.6 units on a scale
STANDARD_DEVIATION 35.09 • n=9 Participants
|
|
Fracture Type
Actual
|
7 Participants
n=9 Participants
|
|
Fracture Type
Impending
|
2 Participants
n=9 Participants
|
|
Actual Bone Fracture Characteristics - Location of Target Fracture
Right Humerus
|
3 Participants
n=7 Participants • Subjects who had actual fracture
|
|
Actual Bone Fracture Characteristics - Location of Target Fracture
Left Humerus
|
4 Participants
n=7 Participants • Subjects who had actual fracture
|
|
Actual Bone Fracture Characteristics - Location
Proximal
|
4 Participants
n=7 Participants • Subjects who had actual fracture
|
|
Actual Bone Fracture Characteristics - Location
Diaphyseal
|
3 Participants
n=7 Participants • Subjects who had actual fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
11-A2
|
3 Participants
n=7 Participants • AO/OTA fracture classification was used to characterize humeral fractures. The first two digits indicate fracture location (11=proximal humerus, 12=humeral shaft, 13=distal humerus). Type A indicates a simple fracture pattern; the final number further defines fracture morphology. Type A fractures are generally considered less complex and more favorable than Type B or Type C fractures.
|
|
Actual Bone Fracture Characteristics - AO Classification
12-A1
|
1 Participants
n=7 Participants • AO/OTA fracture classification was used to characterize humeral fractures. The first two digits indicate fracture location (11=proximal humerus, 12=humeral shaft, 13=distal humerus). Type A indicates a simple fracture pattern; the final number further defines fracture morphology. Type A fractures are generally considered less complex and more favorable than Type B or Type C fractures.
|
|
Actual Bone Fracture Characteristics - AO Classification
12-A2
|
2 Participants
n=7 Participants • AO/OTA fracture classification was used to characterize humeral fractures. The first two digits indicate fracture location (11=proximal humerus, 12=humeral shaft, 13=distal humerus). Type A indicates a simple fracture pattern; the final number further defines fracture morphology. Type A fractures are generally considered less complex and more favorable than Type B or Type C fractures.
|
|
Actual Bone Fracture Characteristics - AO Classification
13-A2
|
1 Participants
n=7 Participants • AO/OTA fracture classification was used to characterize humeral fractures. The first two digits indicate fracture location (11=proximal humerus, 12=humeral shaft, 13=distal humerus). Type A indicates a simple fracture pattern; the final number further defines fracture morphology. Type A fractures are generally considered less complex and more favorable than Type B or Type C fractures.
|
|
Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue
Type I
|
4 Participants
n=5 Participants • Subjects who had actual fracture. Two subjects were missing this information.
|
|
Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue
Type IIA
|
1 Participants
n=5 Participants • Subjects who had actual fracture. Two subjects were missing this information.
|
|
Impending Bone Fracture Characteristics - Location of Target Fracture
Right Humerus
|
2 Participants
n=2 Participants • Subjects who had impending fracture
|
|
Impending Bone Fracture Characteristics - Location of Target Fracture
Left Humerus
|
0 Participants
n=2 Participants • Subjects who had impending fracture
|
|
Impending Bone Fracture Characteristics - Location
Proximal
|
1 Participants
n=2 Participants • Subjects who had impending fracture
|
|
Impending Bone Fracture Characteristics - Location
Diaphyseal
|
1 Participants
n=2 Participants • Subjects who had impending fracture
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=5 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Pain Reduction
>= -33% Change
|
5 Participants
|
|
Pain Reduction
<-33% Change
|
0 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Intent-to-Treat Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=4 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Functional Improvement - Barthel Index
>= 10% Change
|
1 Participants
|
|
Functional Improvement - Barthel Index
<10% Change
|
3 Participants
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Pain Reduction
Day 180 F/U · >= -33% Change
|
4 Participants
|
|
Pain Reduction
Day 180 F/U · <-33% Change
|
0 Participants
|
|
Pain Reduction
Day 360 F/U · >= -33% Change
|
3 Participants
|
|
Pain Reduction
Day 360 F/U · <-33% Change
|
1 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
90 Day F/U
|
-85.4 units on a scale
Standard Deviation 22.02
|
|
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
180 Day F/U
|
-64.5 units on a scale
Standard Deviation 29.41
|
|
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
360 Day F/U
|
-65.0 units on a scale
Standard Deviation 33.60
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat Population. Subjects who had data at the visit.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Functional Improvement - Barthel Index
Day 180 F/U Visit - >=10% Change
|
2 Participants
|
|
Functional Improvement - Barthel Index
360 Day F/U - >=10% Change
|
0 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 DaysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Change From Baseline of Barthel Index of Activities of Daily Living
90 Day F/U
|
9.9 units on a scale
Standard Deviation 30.60
|
|
Change From Baseline of Barthel Index of Activities of Daily Living
180 Day F/U
|
10.5 units on a scale
Standard Deviation 24.64
|
|
Change From Baseline of Barthel Index of Activities of Daily Living
360 Day F/U
|
-1.7 units on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data..
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Functional Improvement - EORTC QLQ-C30
90 Day F/U · >= 10% Change
|
1 Participants
|
|
Functional Improvement - EORTC QLQ-C30
90 Day F/U · <10% Change
|
3 Participants
|
|
Functional Improvement - EORTC QLQ-C30
180 Day F/U · >= 10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-C30
180 Day F/U · <10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-C30
360 Day F/U · >= 10% Change
|
1 Participants
|
|
Functional Improvement - EORTC QLQ-C30
360 Day F/U · <10% Change
|
3 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Functional Improvement - EORTC QLQ-BM22
Day 90 F/U · >= 10% Change
|
3 Participants
|
|
Functional Improvement - EORTC QLQ-BM22
Day 90 F/U · <10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-BM22
Day 180 F/U · >= 10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-BM22
Day 180 F/U · <10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-BM22
Day 360 F/U · >= 10% Change
|
2 Participants
|
|
Functional Improvement - EORTC QLQ-BM22
Day 360 F/U · <10% Change
|
2 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
Surgical interventions include revisions, supplements, fixations and removals
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Surgical Interventions
Day 90 Visit · Yes
|
0 Participants
|
|
Surgical Interventions
Day 90 Visit · No
|
5 Participants
|
|
Surgical Interventions
Day 180 Visit · Yes
|
0 Participants
|
|
Surgical Interventions
Day 180 Visit · No
|
4 Participants
|
|
Surgical Interventions
Day 360 Visit · Yes
|
0 Participants
|
|
Surgical Interventions
Day 360 Visit · No
|
4 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
Summary of device status (intact and in-place)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Device Status
Day 360 Visit · Intact and In-place
|
4 Participants
|
|
Device Status
Day 360 Visit · Not Intact and In-place
|
0 Participants
|
|
Device Status
Day 90 Visit · Intact and In-place
|
5 Participants
|
|
Device Status
Day 90 Visit · Not Intact and In-place
|
0 Participants
|
|
Device Status
Day 180 Visit · Intact and In-place
|
4 Participants
|
|
Device Status
Day 180 Visit · Not Intact and In-place
|
0 Participants
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Intent-to-Treat (ITT) Population. Subjects who had visit data.
Summary of serious device-related complications
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=9 Participants
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Serious Device-Related Complications
Day 90 Visit · Yes
|
2 Participants
|
|
Serious Device-Related Complications
Day 90 Visit · No
|
5 Participants
|
|
Serious Device-Related Complications
Day 180 Visit · Yes
|
0 Participants
|
|
Serious Device-Related Complications
Day 180 Visit · No
|
4 Participants
|
|
Serious Device-Related Complications
Day 360 Visit · Yes
|
0 Participants
|
|
Serious Device-Related Complications
Day 360 Visit · No
|
4 Participants
|
Adverse Events
Photodynamic Bone Stabilization System (PBSS)
Serious events: 10 serious events
Other events: 4 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=14 participants at risk
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
General disorders
Asthenia
|
21.4%
3/14 • Number of events 3 • 1 Year
|
|
General disorders
General physical health deterioration
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Arthritis infective
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pneumococcal sepsis
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Wound infection
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Fat embolism
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
14.3%
2/14 • Number of events 2 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Nervous system disorders
Coma
|
7.1%
1/14 • Number of events 1 • 1 Year
|
Other adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=14 participants at risk
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.
Photodynamic Bone Stabilization System: Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Azotaemia
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
General disorders
Peripheral swelling
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submission of any material for publication or presentation, the Investigator shall jointly provide the sponsor with the material for review. The sponsor may deny such approval only, if any publication of the work results, inventions or findings jeopardizes the confidentiality of business or trade secrets or would impair the issuance of intellectual property rights or if the content of the planned publication is technically incorrect.
- Publication restrictions are in place
Restriction type: OTHER