Trial Outcomes & Findings for Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus (NCT NCT02338492)
NCT ID: NCT02338492
Last Updated: 2018-05-17
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Baseline and 90 days
Results posted on
2018-05-17
Participant Flow
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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
Enrolled
|
81
|
|
Overall Study
Device Implanted
|
79
|
|
Overall Study
Treatment Failure
|
2
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
45
|
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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Overall Study
Death
|
32
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Reason not captured above
|
6
|
Baseline Characteristics
Subjects with Actual Bone Fracture
Baseline characteristics by cohort
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.91 • n=81 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=81 Participants
|
|
Region of Enrollment
United States
|
81 Participants
n=81 Participants
|
|
Actual Bone Fracture Characteristics - Location of Target Fracture
Left Humerus
|
24 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Location of Target Fracture
Right Humerus
|
25 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Location
Proximal
|
25 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Location
Diaphyseal
|
20 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Location
Distal
|
4 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
11-A1
|
1 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
11-A2
|
6 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
11-A3
|
5 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-A1
|
7 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-A2
|
12 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-A3
|
5 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-B1
|
3 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-B2
|
7 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
12-C3
|
1 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
NA
|
1 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - AO Classification
Unknown
|
1 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue
Closed Fracture
|
46 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue
Type I
|
3 Participants
n=49 Participants • Subjects with Actual Bone Fracture
|
|
Impending Bone Fracture Characteristics - Location of Target Fracture
Left Humerus
|
14 Participants
n=32 Participants • Subjects with Impending Bone Fracture
|
|
Impending Bone Fracture Characteristics - Location of Target Fracture
Right Humerus
|
18 Participants
n=32 Participants • Subjects with Impending Bone Fracture
|
|
Impending Bone Fracture Characteristics - Location
Proximal
|
22 Participants
n=32 Participants • Subjects with Impending Bone Fracture
|
|
Impending Bone Fracture Characteristics - Location
Diaphyseal
|
9 Participants
n=32 Participants • Subjects with Impending Bone Fracture
|
|
Impending Bone Fracture Characteristics - Location
Distal
|
1 Participants
n=32 Participants • Subjects with Impending Bone Fracture
|
PRIMARY outcome
Timeframe: Baseline and 90 daysPopulation: Number of subjects who had a Day 90 visit
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).
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=56 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Change in Pain
|
-52.7 units on a scale
Standard Error 3.62
|
PRIMARY outcome
Timeframe: Baseline and 90 daysPopulation: Subjects who had 90 Day data
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=52 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Change in Function
|
39.23 units on a scale
Standard Error 2.929
|
PRIMARY outcome
Timeframe: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Summary of Clinical Safety Success
Up to D90 : No device fracture, migration
|
76 Participants
|
|
Summary of Clinical Safety Success
Up to D90 : Safety Success
|
75 Participants
|
|
Summary of Clinical Safety Success
Up to D180 : No serious dev rel complications
|
76 Participants
|
|
Summary of Clinical Safety Success
Up to D180 : No additional surgical intervention
|
77 Participants
|
|
Summary of Clinical Safety Success
Up to D7-14 : No serious dev rel complications
|
81 Participants
|
|
Summary of Clinical Safety Success
Up to D7-14 : No additional surgical intervention
|
81 Participants
|
|
Summary of Clinical Safety Success
Up to D7-14 : No device fracture, migration
|
80 Participants
|
|
Summary of Clinical Safety Success
Up to D7-14 : Safety Success
|
80 Participants
|
|
Summary of Clinical Safety Success
Up to D30 : No serious dev rel complications
|
80 Participants
|
|
Summary of Clinical Safety Success
Up to D30 : No additional surgical intervention
|
80 Participants
|
|
Summary of Clinical Safety Success
Up to D30 : No device fracture, migration
|
78 Participants
|
|
Summary of Clinical Safety Success
Up to D30 : Safety Success
|
78 Participants
|
|
Summary of Clinical Safety Success
Up to D90 : No serious dev rel complications
|
78 Participants
|
|
Summary of Clinical Safety Success
Up to D90 : No additional surgical intervention
|
80 Participants
|
|
Summary of Clinical Safety Success
Up to D180 : No device fracture, migration
|
70 Participants
|
|
Summary of Clinical Safety Success
Up to D180 : Safety Success
|
70 Participants
|
|
Summary of Clinical Safety Success
Up to D360 : No serious dev rel complications
|
74 Participants
|
|
Summary of Clinical Safety Success
Up to D360 : No additional surgical intervention
|
74 Participants
|
|
Summary of Clinical Safety Success
Up to D360 : No device fracture, migration
|
67 Participants
|
|
Summary of Clinical Safety Success
Up to D360 : Safety Success
|
67 Participants
|
SECONDARY outcome
Timeframe: 90, 180 and 360 daysPopulation: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
Pain on palpation and clinical significance
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Pain at Palpation
90 Day F/U · Pain on palpation Yes Clinically Si
|
4 Participants
|
|
Pain at Palpation
90 Day F/U · Pain on palpation Yes Not Clinically Sig
|
7 Participants
|
|
Pain at Palpation
90 Day F/U · Pain on palpation No
|
42 Participants
|
|
Pain at Palpation
90 Day F/U · Pain on palpation Not Done
|
1 Participants
|
|
Pain at Palpation
180 Day F/U · Pain on palpation Yes Clinically Si
|
8 Participants
|
|
Pain at Palpation
180 Day F/U · Pain on palpation Yes Not Clinically Sig
|
12 Participants
|
|
Pain at Palpation
180 Day F/U · Pain on palpation No
|
25 Participants
|
|
Pain at Palpation
180 Day F/U · Pain on palpation Not Done
|
4 Participants
|
|
Pain at Palpation
360 Day F/U · Pain on palpation Yes Clinically Si
|
3 Participants
|
|
Pain at Palpation
360 Day F/U · Pain on palpation Yes Not Clinically Sig
|
4 Participants
|
|
Pain at Palpation
360 Day F/U · Pain on palpation No
|
27 Participants
|
|
Pain at Palpation
360 Day F/U · Pain on palpation Not Done
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 DayDuration of index procedure (hours)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Duration of Index Procedure
|
1.64 hours
Standard Deviation 1.221
|
SECONDARY outcome
Timeframe: Baseline, 90, 180 and 360 daysPopulation: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Activities of Daily Living Score Through All Follow-up Intervals
Psychosocial Aspects, 180 Day F/U
|
12.48 units on a scale
Standard Deviation 25.522
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Psychosocial Aspects, 360 Day F/U
|
16.36 units on a scale
Standard Deviation 26.056
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Painful Sites, 90 Day F/U
|
-6.55 units on a scale
Standard Deviation 17.093
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Painful Sites, 180 Day F/U
|
-5.56 units on a scale
Standard Deviation 17.029
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Painful Sites, 360 Day F/U
|
-5.19 units on a scale
Standard Deviation 18.248
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Pain Characteristics, 90 Day F/U
|
-32.12 units on a scale
Standard Deviation 29.988
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Pain Characteristics, 180 Day F/U
|
-28.94 units on a scale
Standard Deviation 33.115
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Pain Characteristics, 360 Day F/U
|
-37.35 units on a scale
Standard Deviation 32.655
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Functional Interference, 90 Day F/U
|
30.41 units on a scale
Standard Deviation 29.362
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Functional Interference, 180 Day F/U
|
28.86 units on a scale
Standard Deviation 33.357
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Functional Interference, 360 Day F/U
|
35.12 units on a scale
Standard Deviation 31.625
|
|
Activities of Daily Living Score Through All Follow-up Intervals
Psychosocial Aspects, 90 Day F/U
|
12.73 units on a scale
Standard Deviation 22.316
|
SECONDARY outcome
Timeframe: 90, 180, 360 daysPopulation: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
MSTS Upper Extremity Functional Outcome
90 Day F/U
|
40.13 units on a scale
Standard Deviation 23.607
|
|
MSTS Upper Extremity Functional Outcome
180 Day F/U
|
44.15 units on a scale
Standard Deviation 26.507
|
|
MSTS Upper Extremity Functional Outcome
360 Day F/U
|
54.75 units on a scale
Standard Deviation 22.608
|
SECONDARY outcome
Timeframe: Surgery & Discharge, 7-14, 30, 90, 180, 360 daysNumber and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Assessment of Post-Surgery Status
Surgery/Discharge: Physical therapy prescribed
|
27 Participants
|
|
Assessment of Post-Surgery Status
Surgery/Discharge: Supportive orth dev recommend
|
64 Participants
|
|
Assessment of Post-Surgery Status
SurgeryDischarge: Analgesic med prescribed
|
74 Participants
|
|
Assessment of Post-Surgery Status
Surgery/Discharge: Completed physical therapy
|
NA Participants
Not applicable for this visit
|
|
Assessment of Post-Surgery Status
Surgery/Discharge: Used supportive orth devices
|
NA Participants
Not applicable for this visit
|
|
Assessment of Post-Surgery Status
30 Day F/U: Completed physical therapy
|
32 Participants
|
|
Assessment of Post-Surgery Status
30 Day F/U: Used supportive orthopedic devices
|
27 Participants
|
|
Assessment of Post-Surgery Status
30 Day F/U: Used analgesic medication
|
51 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Used analgesic medication
|
33 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Physical therapy prescribed
|
2 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Supportive orth device recommended
|
2 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Analgesic medication prescribed
|
2 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Completed physical therapy
|
8 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Used supportive orthopedic devices
|
2 Participants
|
|
Assessment of Post-Surgery Status
360 Day F/U: Used analgesic medication
|
28 Participants
|
|
Assessment of Post-Surgery Status
Surgery/Discharge: Used analgesic medication
|
NA Participants
Not applicable for this visit
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Physical therapy prescribed
|
29 Participants
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Supportive orth dev recommend
|
28 Participants
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Analgesic medication prescribed
|
17 Participants
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Completed physical therapy
|
26 Participants
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Used supportive orthopedic devices
|
48 Participants
|
|
Assessment of Post-Surgery Status
7-14 Day F/U: Used analgesic medication
|
64 Participants
|
|
Assessment of Post-Surgery Status
30 Day F/U: Physical therapy prescribed
|
26 Participants
|
|
Assessment of Post-Surgery Status
30 Day F/U: Supportive orth recommend
|
13 Participants
|
|
Assessment of Post-Surgery Status
30 Day F/U: Analgesic medication prescribed
|
19 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U: Physical therapy prescribed
|
17 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U: Supportive orthopedic dev recommend
|
6 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U: Analgesic medication prescribed
|
8 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U: Completed physical therapy
|
31 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U: Used supportive orthopedic devices
|
11 Participants
|
|
Assessment of Post-Surgery Status
90 Day F/U : Used analgesic medication
|
41 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Physical therapy prescribed
|
12 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Supportive orth device recommend
|
7 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Analgesic medication prescribed
|
6 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Completed physical therapy
|
23 Participants
|
|
Assessment of Post-Surgery Status
180 Day F/U: Used supportive orthopedic devices
|
4 Participants
|
SECONDARY outcome
Timeframe: up to day 90, up to day180 since day 90, up to 360 since day 180Procedure and device-related complications rate presented at follow-up visits
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Summary of Procedure and Device-Related Complications Rate
Procedure & device-related complications up to D90 · During device preparation
|
0 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Procedure & device-related complications up to D90 · During device implantation
|
1 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Procedure & device-related complications up to D90 · Post-implantation
|
3 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Procedure & device-related complications up to D90 · None
|
77 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up D180 since D90 · During device preparation
|
NA Participants
Post-op visit
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up D180 since D90 · During device implantation
|
NA Participants
Post-op visit
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up D180 since D90 · Post-implantation
|
6 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up D180 since D90 · None
|
75 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up to D360 since D180 · During device preparation
|
NA Participants
Post-op visit
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up to D360 since D180 · During device implantation
|
NA Participants
Post-op visit
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up to D360 since D180 · Post-implantation
|
4 Participants
|
|
Summary of Procedure and Device-Related Complications Rate
Proc & dev-related comp rate up to D360 since D180 · None
|
77 Participants
|
SECONDARY outcome
Timeframe: Baseline, 90, 180 and 360 DaysPopulation: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
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.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Abduction, Active ROM affected arm
|
41.0 degrees
Standard Deviation 36.04
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U Abduction, Passive ROM affected arm
|
31.2 degrees
Standard Deviation 37.71
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Abduction, Active ROM affected arm
|
54.9 degrees
Standard Deviation 44.42
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Abduction, Passive ROM affected arm
|
46.3 degrees
Standard Deviation 51.24
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Abduction, Active ROM unaffected arm
|
2 degrees
Standard Deviation 32.14
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Abduction, Pass ROM unaffected arm
|
-0.5 degrees
Standard Deviation 29.19
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Abduction, Active ROM unaffected arm
|
4.9 degrees
Standard Deviation 33.29
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Abduction, Passive ROM unaffected arm
|
6.0 degrees
Standard Deviation 32.46
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Abduction, Active ROM unaffected arm
|
19.1 degrees
Standard Deviation 43.62
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Abduction, Passive ROM unaffected arm
|
16.0 degrees
Standard Deviation 42.13
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Extension, Active ROM affected arm
|
12 degrees
Standard Deviation 14.88
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Extension, Passive ROM affected arm
|
11.7 degrees
Standard Deviation 17.01
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Extension, Active ROM affected arm
|
8.1 degrees
Standard Deviation 16.17
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Extension, Passive ROM affected arm
|
4.8 degrees
Standard Deviation 17.15
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Extension, Active ROM affected arm
|
10.3 degrees
Standard Deviation 19.75
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Extension, Passive ROM affected arm
|
7.7 degrees
Standard Deviation 21.83
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Extension, Active ROM unaffected arm
|
0.6 degrees
Standard Deviation 13.87
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Extension, Passive ROM unaffected arm
|
-1.0 degrees
Standard Deviation 14.12
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Extension, Active ROM unaffected arm
|
-4.1 degrees
Standard Deviation 17.96
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Extension, Passive ROM unaffected arm
|
-4.1 degrees
Standard Deviation 17.41
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Extension, Active ROM unaffected arm
|
3.5 degrees
Standard Deviation 19.90
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Extension, Passive ROM unaffected arm
|
5.5 degrees
Standard Deviation 27.24
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Flexion, Active ROM affected arm
|
28.7 degrees
Standard Deviation 36.61
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Flexion, Passive ROM affected arm
|
28.5 degrees
Standard Deviation 45.27
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Lat Rotate, Passive ROM affected arm
|
8.6 degrees
Standard Deviation 23.61
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Lat Rotate, Active ROM affected arm
|
12.4 degrees
Standard Deviation 31.38
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Lat Rotate, Passive ROM affected arm
|
6.5 degrees
Standard Deviation 30.69
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Lat Rotate, Active ROM affected arm
|
16.6 degrees
Standard Deviation 22.79
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Lat Rotate, Passive ROM affected arm
|
13.6 degrees
Standard Deviation 20.99
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Lat Rotate, Active ROM unaffected arm
|
0.5 degrees
Standard Deviation 14.95
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Lat Rotate, Passive ROM unaffected arm
|
0.3 degrees
Standard Deviation 14.18
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Lat Rotate, Active ROM unaffected arm
|
-3.6 degrees
Standard Deviation 18.67
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Lat Rotate, Passive ROM unaffect arm
|
-6.0 degrees
Standard Deviation 19.14
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Lat Rotate, Active ROM unaffected arm
|
1.8 degrees
Standard Deviation 20.25
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Lat Rotate, Passive ROM unaffect arm
|
-0.22 degrees
Standard Deviation 25.656
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Med Rotate, Active ROM affected arm
|
11.7 degrees
Standard Deviation 28.78
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Med Rotate, Passive ROM affected arm
|
7.5 degrees
Standard Deviation 25.90
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Med Rotate, Active ROM affected arm
|
2.2 degrees
Standard Deviation 31.21
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Med Rotate, Passive ROM affected arm
|
3.1 degrees
Standard Deviation 34.14
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Med Rotate, Active ROM affected arm
|
6.4 degrees
Standard Deviation 27.46
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Med Rotate, Active ROM unaffected arm
|
2.6 degrees
Standard Deviation 19.15
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Med Rotate, Passive ROM unaffect arm
|
2.5 degrees
Standard Deviation 18.76
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Abduction, Active ROM affected arm
|
31.3 degrees
Standard Deviation 33.36
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Abduction, Passive ROM affected arm
|
29.1 degrees
Standard Deviation 38.22
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Flexion, Active ROM affected arm
|
33.1 degrees
Standard Deviation 39.90
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Flexion, Passive ROM affected arm
|
29.4 degrees
Standard Deviation 45.35
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Flexion, Active ROM affected arm
|
46.6 degrees
Standard Deviation 51.17
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Flexion, Passive ROM affected arm
|
36.7 degrees
Standard Deviation 52.28
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Flexion, Active ROM unaffected arm
|
5.6 degrees
Standard Deviation 29.85
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Flexion, Passive ROM unaffected arm
|
3.7 degrees
Standard Deviation 29.02
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Flexion, Active ROM unaffected arm
|
3.0 degrees
Standard Deviation 35.86
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Flexion, Passive ROM unaffected arm
|
1.8 degrees
Standard Deviation 34.72
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Flexion, Active ROM unaffected arm
|
7.5 degrees
Standard Deviation 42.01
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Flexion, Passive ROM unaffected arm
|
4.7 degrees
Standard Deviation 41.50
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Lat Rotate, Active ROM affected arm
|
10.4 degrees
Standard Deviation 22.51
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
360 Day F/U, Med Rotate, Passive ROM affected arm
|
6.3 degrees
Standard Deviation 24.28
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Med Rotate, Active ROM unaffected arm
|
1.7 degrees
Standard Deviation 14.43
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
90 Day F/U, Med Rotate, Passive ROM unaffected arm
|
2.89 degrees
Standard Deviation 20.939
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Med Rotate, Active ROM unaffected arm
|
-1.3 degrees
Standard Deviation 14.72
|
|
Summary of Change From Baseline Range of Motion by Visit and Test
180 Day F/U, Med Rotate, Passive ROM unaffect arm
|
0.8 degrees
Standard Deviation 9.85
|
SECONDARY outcome
Timeframe: From day of procedure until the day of hospital discharge (up to 36 days)Length of hospital stay (from day of procedure to day of discharge)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Length of Hospital Stay
|
5.1 Days
Standard Deviation 6.14
|
Adverse Events
Photodynamic Bone Stabilization System (PBSS)
Serious events: 58 serious events
Other events: 49 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
General disorders
Medical device site pain
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
General disorders
Adverse drug reaction
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
General disorders
Asthenia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
General disorders
Systemic inflammatory response syndrome
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Infections and infestations
Cellulitis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Infections and infestations
Post procedural pneumonia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Overdose
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
11.1%
9/81 • Number of events 9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
8.6%
7/81 • Number of events 7 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.6%
7/81 • Number of events 7 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endotheliomatosis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer stage IV
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cauda equina syndrome
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Nervous system disorders
Seizure
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Product Issues
Device breakage
|
8.6%
7/81 • Number of events 7 • 1 year
|
|
Product Issues
Device dislocation
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Disorientation
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Social circumstances
Activities of daily living impaired
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/81 • Number of events 1 • 1 year
|
|
Vascular disorders
Jugular vein thrombosis
|
1.2%
1/81 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=81 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
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.4%
6/81 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
General disorders
Fatigue
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
General disorders
Medical device site pain
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
General disorders
Medical device site swelling
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
General disorders
Peripheral swelling
|
7.4%
6/81 • Number of events 6 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Investigations
Haemoglobin decreased
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
4/81 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
3.7%
3/81 • Number of events 3 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
2.5%
2/81 • Number of events 2 • 1 year
|
|
Product Issues
Device breakage
|
8.6%
7/81 • Number of events 7 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/81 • Number of events 2 • 1 year
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall submit copies of any material to sponsor for review at least 30 days in advance of submission to a publisher or other third party. The sponsor shall review the data provided for consistency and reserves the right to delete any confidential information or other proprietary information from the proposed material. Sponsor may extend such review period for another 60 days to allow for filing of patent applications or take other steps to protect the sponsor's IP interests.
- Publication restrictions are in place
Restriction type: OTHER