Trial Outcomes & Findings for Safety and Efficacy Study of the Treatment of Humerus Fractures (NCT NCT02394080)
NCT ID: NCT02394080
Last Updated: 2026-07-15
Results Overview
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
180 days
Results posted on
2026-07-15
Participant Flow
44 patients signed the informed consent form. 44 is the modified intent to treat group, 33 is the intent to treat group
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 acute humerus fractures
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
37
|
|
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 acute humerus fractures
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 10.16 • n=33 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=33 Participants
|
|
Region of Enrollment
Netherlands
|
22 Participants
n=33 Participants
|
|
Region of Enrollment
Germany
|
11 Participants
n=33 Participants
|
|
Location of Target Fracture
Left Humerus
|
23 Participants
n=33 Participants
|
|
Location of Target Fracture
Right Humerus
|
10 Participants
n=33 Participants
|
|
Location
Proximal
|
32 Participants
n=33 Participants
|
|
Location
Diaphyseal
|
1 Participants
n=33 Participants
|
|
Location
Distal
|
0 Participants
n=33 Participants
|
|
AO Classification
02-A3
|
0 Participants
n=33 Participants
|
|
AO Classification
11-A1
|
1 Participants
n=33 Participants
|
|
Traumatic Injury Specify
Other
|
10 Participants
n=12 Participants • ITT population, subjects who had Traumatic Injury
|
|
AO Classification
11-A2
|
8 Participants
n=33 Participants
|
|
AO Classification
11-A3
|
2 Participants
n=33 Participants
|
|
AO Classification
11-B1
|
9 Participants
n=33 Participants
|
|
AO Classification
11-B2
|
13 Participants
n=33 Participants
|
|
AO Classification
11-C2
|
0 Participants
n=33 Participants
|
|
Gustilo Grading of Soft Tissue
Closed
|
26 Participants
n=33 Participants
|
|
Gustilo Grading of Soft Tissue
Type I
|
7 Participants
n=33 Participants
|
|
Neer's Fracture Grading
N/A
|
4 Participants
n=33 Participants
|
|
Neer's Fracture Grading
2-part
|
11 Participants
n=33 Participants
|
|
Neer's Fracture Grading
3-part
|
14 Participants
n=33 Participants
|
|
Neer's Fracture Grading
4-part
|
4 Participants
n=33 Participants
|
|
Type of Injury
Traumatic
|
12 Participants
n=33 Participants
|
|
Type of Injury
Non-Traumatic, low energy fall
|
20 Participants
n=33 Participants
|
|
Type of Injury
Non-Traumatic
|
1 Participants
n=33 Participants
|
|
Traumatic Injury Specify
Sports Injury
|
2 Participants
n=12 Participants • ITT population, subjects who had Traumatic Injury
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Intent-to-Treat Population, subjects with a valid assessment
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=26 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 acute humerus fractures
|
|---|---|
|
Normal Radiographic Fracture Healing
Normal Healing
|
25 Participants
|
|
Normal Radiographic Fracture Healing
Not Normal Healing
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects with valid assessment.
Three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (greater than or equal to 75% on orthogonal views) of fracture lines
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Evaluation of Complete Radiographic Healing
Day 180 Visit · Complete Healing
|
23 Participants
|
|
Evaluation of Complete Radiographic Healing
Day 180 Visit · Not Complete Healing
|
3 Participants
|
|
Evaluation of Complete Radiographic Healing
Day 360 Visit · Complete Healing
|
27 Participants
|
|
Evaluation of Complete Radiographic Healing
Day 360 Visit · Not Complete Healing
|
1 Participants
|
SECONDARY outcome
Timeframe: 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects with a valid assessment.
Two of four cortices or two of four views demonstrating bridging on standard radiographs
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=28 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 acute humerus fractures
|
|---|---|
|
Evaluation of Normal Radiographic Healing
Normal Healing
|
27 Participants
|
|
Evaluation of Normal Radiographic Healing
Not Normal Healing
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had a visit.
Change from baseline of pain visual analog score (VAS). Participants indicate their pain level by marking a point along a continuous horizontal line anchored by "No Pain" and "Severe Pain. Total score range: 0 to 100 units on a scale 0 = No pain 100 = Severe pain. Lower scores represent a better outcome (less pain), while higher scores represent a worse outcome (greater pain)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Pain VAS
180 day follow-up
|
-39.1 units on a scale
Standard Deviation 26.94
|
|
Summary of Pain VAS
360 day follow-up
|
-50.2 units on a scale
Standard Deviation 33.85
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Change from baseline of disability of the arm shoulder and hand (DASH) score. DASH Disability/Symptom Total Score range: 0 to 100 units on a scale 0 = No disability/symptoms; 100 = Most severe disability/symptoms. Each item is scored on a 5-point Likert scale. Lower scores represent a better outcome (less disability and fewer symptoms), while higher scores represent a worse outcome (greater disability and more severe symptoms)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of DASH Score
180 day follow-up
|
-35.996 units on a scale
Standard Deviation 34.8306
|
|
Summary of DASH Score
360 day follow-up
|
-42.717 units on a scale
Standard Deviation 30.9444
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Change from baseline of constant shoulder score. Total Constant Score range: 0 to 100 units on a scale 0 = Worst shoulder function; 100 = Best shoulder function. The total Constant Score is calculated by summing the four subscale scores for a maximum of 100 points. Higher scores represent a better outcome (improved shoulder function and less pain), while lower scores represent a worse outcome (greater disability and impaired shoulder function).
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Constant Shoulder Score
180 day follow-up
|
22.869 units on a scale
Standard Deviation 31.3947
|
|
Summary of Constant Shoulder Score
360 day follow-up
|
27.324 units on a scale
Standard Deviation 29.3379
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Pain at Palpation (yes/no), grade and clinical significance. Grade: mild, moderate, severe
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Pain on Palpation
180 day follow-up · No
|
26 Participants
|
|
Summary of Pain on Palpation
180 day follow-up · Yes, Mild, Not Clinically Significant
|
1 Participants
|
|
Summary of Pain on Palpation
360 day follow-up · No
|
27 Participants
|
|
Summary of Pain on Palpation
360 day follow-up · Yes, Mild, Not Clinically Significant
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Summary of subjects who returned to pre-fracture mobility (yes/no)
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Return to Pre-Fracture Mobility
180 day follow-up · No
|
22 Participants
|
|
Summary of Return to Pre-Fracture Mobility
180 day follow-up · Yes
|
5 Participants
|
|
Summary of Return to Pre-Fracture Mobility
360 day follow-up · No
|
19 Participants
|
|
Summary of Return to Pre-Fracture Mobility
360 day follow-up · Yes
|
9 Participants
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Summary of range of motion (active and passive) for affected and unaffected arm, for abduction, flexion, extension and lateral and medial rotation.
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Range of Motion
360D F/U, Active ROM Unaffected Arm, Abduction
|
148.4 Unit of measure, Degrees
Standard Deviation 38.34
|
|
Summary of Range of Motion
360D F/U, Active ROM Unaffected Arm, Flexion
|
145.3 Unit of measure, Degrees
Standard Deviation 40.47
|
|
Summary of Range of Motion
360D F/U, Active ROM Unaffected Arm, Extension
|
76.6 Unit of measure, Degrees
Standard Deviation 38.52
|
|
Summary of Range of Motion
360D F/U, Active ROM Unaffected Arm, Lat Rotation
|
56.6 Unit of measure, Degrees
Standard Deviation 15.99
|
|
Summary of Range of Motion
360D F/U, Active ROM Unaffected Arm, Med Rotation
|
90.0 Unit of measure, Degrees
Standard Deviation 24.72
|
|
Summary of Range of Motion
360D F/U, Passive ROM Unaffected Arm, Abduction
|
157.7 Unit of measure, Degrees
Standard Deviation 31.01
|
|
Summary of Range of Motion
360D F/U, Passive ROM Unaffected Arm, Flexion
|
153.3 Unit of measure, Degrees
Standard Deviation 36.62
|
|
Summary of Range of Motion
360D F/U, Passive ROM Unaffected Arm, Extension
|
72.5 Unit of measure, Degrees
Standard Deviation 30.11
|
|
Summary of Range of Motion
360D F/U, Passive ROM Unaffected Arm, Lat Rotation
|
60.3 Unit of measure, Degrees
Standard Deviation 15.38
|
|
Summary of Range of Motion
360D F/U, Passive ROM Unaffected Arm, Med Rotation
|
91.7 Unit of measure, Degrees
Standard Deviation 27.49
|
|
Summary of Range of Motion
180D F/U, Active ROM Unaffected Arm, Med Rotation
|
92.4 Unit of measure, Degrees
Standard Deviation 19.29
|
|
Summary of Range of Motion
180D F/U, Passive ROM Unaffected Arm, Abduction
|
168.8 Unit of measure, Degrees
Standard Deviation 25.22
|
|
Summary of Range of Motion
180D F/U, Passive ROM Unaffected Arm, Flexion
|
167.9 Unit of measure, Degrees
Standard Deviation 20.54
|
|
Summary of Range of Motion
180D F/U, Passive ROM Unaffected Arm, Extension
|
66.5 Unit of measure, Degrees
Standard Deviation 13.67
|
|
Summary of Range of Motion
180D F/U, Passive ROM Unaffected Arm, Lat Rotation
|
63.8 Unit of measure, Degrees
Standard Deviation 16.35
|
|
Summary of Range of Motion
180D F/U, Passive ROM Unaffected Arm, Med Rotation
|
93.2 Unit of measure, Degrees
Standard Deviation 20.23
|
|
Summary of Range of Motion
360D F/U, Active ROM Affected Arm, Abduction
|
102.2 Unit of measure, Degrees
Standard Deviation 38.46
|
|
Summary of Range of Motion
360D F/U, Active ROM Affected Arm, Flexion
|
93.2 Unit of measure, Degrees
Standard Deviation 39.13
|
|
Summary of Range of Motion
360D F/U, Active ROM Affected Arm, Extension
|
74.0 Unit of measure, Degrees
Standard Deviation 40.75
|
|
Summary of Range of Motion
360D F/U, Active ROM Affected Arm, Lat Rotation
|
38.0 Unit of measure, Degrees
Standard Deviation 19.53
|
|
Summary of Range of Motion
360D F/U, Active ROM Affected Arm, Med Rotation
|
82.4 Unit of measure, Degrees
Standard Deviation 20.82
|
|
Summary of Range of Motion
360D F/U, Passive ROM Affected Arm, Abduction
|
109.0 Unit of measure, Degrees
Standard Deviation 37.67
|
|
Summary of Range of Motion
360D F/U, Passive ROM Affected Arm, Flexion
|
98.4 Unit of measure, Degrees
Standard Deviation 38.10
|
|
Summary of Range of Motion
360D F/U, Passive ROM Affected Arm, Extension
|
82.8 Unit of measure, Degrees
Standard Deviation 42.48
|
|
Summary of Range of Motion
360D F/U, Passive ROM Affected Arm, Lat Rotation
|
41.8 Unit of measure, Degrees
Standard Deviation 18.70
|
|
Summary of Range of Motion
360D F/U, Passive ROM Affected Arm, Med Rotation
|
84.6 Unit of measure, Degrees
Standard Deviation 23.49
|
|
Summary of Range of Motion
180D F/U, Active ROM Affected Arm, Abduction
|
78.8 Unit of measure, Degrees
Standard Deviation 34.12
|
|
Summary of Range of Motion
180D F/U, Active ROM Affected Arm, Flexion
|
84.0 Unit of measure, Degrees
Standard Deviation 36.98
|
|
Summary of Range of Motion
180D F/U, Active ROM Affected Arm, Extension
|
61.0 Unit of measure, Degrees
Standard Deviation 31.83
|
|
Summary of Range of Motion
180D F/U, Active ROM Affected Arm, Lat Rotation
|
36.0 Unit of measure, Degrees
Standard Deviation 16.28
|
|
Summary of Range of Motion
180D F/U, Active ROM Affected Arm, Med Rotation
|
79.2 Unit of measure, Degrees
Standard Deviation 17.24
|
|
Summary of Range of Motion
180D F/U, Passive ROM Affected Arm, Abduction
|
94.3 Unit of measure, Degrees
Standard Deviation 33.00
|
|
Summary of Range of Motion
180D F/U, Passive ROM Affected Arm, Flexion
|
93.3 Unit of measure, Degrees
Standard Deviation 38.92
|
|
Summary of Range of Motion
180D F/U, Passive ROM Affected Arm, Extension
|
68.7 Unit of measure, Degrees
Standard Deviation 31.56
|
|
Summary of Range of Motion
180D F/U, Passive ROM Affected Arm, Lat Rotation
|
43.0 Unit of measure, Degrees
Standard Deviation 16.36
|
|
Summary of Range of Motion
180D F/U, Passive ROM Affected Arm, Med Rotation
|
87.4 Unit of measure, Degrees
Standard Deviation 18.21
|
|
Summary of Range of Motion
180D F/U, Active ROM Unaffected Arm, Abduction
|
170.6 Unit of measure, Degrees
Standard Deviation 14.78
|
|
Summary of Range of Motion
180D F/U, Active ROM Unaffected Arm, Flexion
|
168.8 Unit of measure, Degrees
Standard Deviation 11.11
|
|
Summary of Range of Motion
180D F/U, Active ROM Unaffected Arm, Extension
|
64.4 Unit of measure, Degrees
Standard Deviation 14.02
|
|
Summary of Range of Motion
180D F/U, Active ROM Unaffected Arm, Lat Rotation
|
61.5 Unit of measure, Degrees
Standard Deviation 16.18
|
SECONDARY outcome
Timeframe: 180 and 360 daysPopulation: Intent-to-Treat (ITT) Population, subjects who had visit data.
Disability status as determined by the investigator
Outcome measures
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Summary of Disability Status
360 day follow-up · Disabled
|
2 Participants
|
|
Summary of Disability Status
180 day follow-up · Disabled
|
3 Participants
|
|
Summary of Disability Status
360 day follow-up · Not Disabled
|
26 Participants
|
|
Summary of Disability Status
180 day follow-up · Not Disabled
|
24 Participants
|
Adverse Events
Photodynamic Bone Stabilization System (PBSS)
Serious events: 14 serious events
Other events: 14 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma metastatic
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Nervous system disorders
Sciatica
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
General disorders
Device dislocation
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
General disorders
Device extrusion
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
General disorders
Implant site reaction
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
General disorders
Sudden cardiac death
|
3.0%
1/33 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
3.0%
1/33 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Photodynamic Bone Stabilization System (PBSS)
n=33 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 acute humerus fractures
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.1%
4/33 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Infections and infestations
Pneumonia
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Wound secretion
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
Nervous system disorders
Syncope
|
6.1%
2/33 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Confusional state
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
9.1%
3/33 • Number of events 3 • 1 year
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • Number of events 2 • 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