Trial Outcomes & Findings for The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury (NCT NCT02138110)
NCT ID: NCT02138110
Last Updated: 2024-01-17
Results Overview
The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows: A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5 B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2) D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade \>3 E = Normal The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 months post-implantation
Results posted on
2024-01-17
Participant Flow
Participant milestones
| Measure |
Neuro-Spinal Scaffold
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Enrolled in Study
STARTED
|
20
|
|
Enrolled in Study
COMPLETED
|
20
|
|
Enrolled in Study
NOT COMPLETED
|
0
|
|
Enrolled for Scaffold Implantation
STARTED
|
20
|
|
Enrolled for Scaffold Implantation
COMPLETED
|
19
|
|
Enrolled for Scaffold Implantation
NOT COMPLETED
|
1
|
|
Overall Scaffold Implantation
STARTED
|
19
|
|
Overall Scaffold Implantation
6-month Follow-Up
|
16
|
|
Overall Scaffold Implantation
COMPLETED
|
16
|
|
Overall Scaffold Implantation
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Neuro-Spinal Scaffold
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Enrolled for Scaffold Implantation
Physician Decision
|
1
|
|
Overall Scaffold Implantation
Death
|
3
|
Baseline Characteristics
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Neuro-Spinal Scaffold
n=20 Participants
Implantation of neuro-spinal scaffold in a cavity at the epicenter of the spinal cord contusion during open spine surgery.
Neuro-Spinal Scaffold
|
|---|---|
|
Age, Continuous
|
36 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
16 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=93 Participants
|
|
Height
|
172 cm
n=93 Participants
|
|
Weight
|
83 kg
n=93 Participants
|
|
Body Mass Index
|
28 kg/m^2
n=93 Participants
|
|
Cause of Injury
Fall
|
5 Participants
n=93 Participants
|
|
Cause of Injury
Other-All Terrain Vehicle
|
1 Participants
n=93 Participants
|
|
Cause of Injury
Vehicular
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 months post-implantationPopulation: The Primary Endpoint Analysis Set includes all subjects who had a successful Neuro-Spinal Scaffold implant, no major data protocol deviations, and completed the 6-month Primary Endpoint Follow-up Visit.
The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows: A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5 B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2) D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade \>3 E = Normal The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Percentage of Patients With Improvement in AIS Grade of One or More Levels
|
44 percentage of patients
|
SECONDARY outcome
Timeframe: 6 months post-implantationThe neurological level of injury (NLI) refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally. A caudal change is an improvement in NLI whereas a rostral change is a deterioration in NLI. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
Caudal change in NLI from baseline
|
5 Participants
|
|
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
Rostral change in NLI from baseline
|
8 Participants
|
|
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
No change in NLI from baseline
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months post-implantationInternational Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Pin Prick Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in pin prick score indicates an increase in score from baseline at 6-months A deterioration in pin prick score indicates a decrease in score from baseline at 6-months No change in pin prick score indicates no change in score from baseline at 6-months
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
Improvement
|
10 Participants
|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
Deterioration
|
6 Participants
|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
No change
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post-implantationInternational Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Light Touch Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in light touch score indicates an increase in light touch score from baseline at 6-months A deterioration in light touch score indicates a decrease in light touch score from baseline at 6-months No change in light touch score indicates no change in light touch score from baseline at 6-months
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Deterioration
|
4 Participants
|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Improvement
|
10 Participants
|
|
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
No change
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post-implantationPopulation: Results from 15 of 16 patients are presented. This is because pre-implantation assessment was not testable for 1 of 16 patients.
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Total Motor Scores were assessed on a scale from 0 to 5 for each myotome tested on each side of the body (upper limb maximum score = 50 and lower limb maximum score = 50), with higher scores indicating better neurologic function. The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit. An improvement in motor score indicates an increase in motor score from baseline at 6-months A deterioration in motor score indicates an decrease in motor score from baseline at 6-months No change in motor score indicates no change in motor score from baseline at 6-months
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=15 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Change From Baseline in ISNCSCI Total Motor Score
Improvement
|
1 Participants
|
|
Change From Baseline in ISNCSCI Total Motor Score
Deterioration
|
0 Participants
|
|
Change From Baseline in ISNCSCI Total Motor Score
No Change
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 months post-implantationCharacteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including presence or absence of intraparenchymal cysts. Screening MRI was used as the baseline value.
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Cyst Detected
|
9 Participants
|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
No Cyst Detected
|
5 Participants
|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Indeterminate
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post-implantationCharacteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including the presence or absence of spinal cord adhesion. Screening MRI was used as the baseline value.
Outcome measures
| Measure |
Neuro-Spinal Scaffold
n=16 Participants
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Spinal Cord Adhesion Detected
|
1 Participants
|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
No Spinal Cord Adhesion Detected
|
13 Participants
|
|
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Indeterminate
|
2 Participants
|
Adverse Events
Neuro-Spinal Scaffold
Serious events: 19 serious events
Other events: 19 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Neuro-Spinal Scaffold
n=19 participants at risk
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Epididymitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Postoperative wound infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Necrotising myositis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Spinal cord disorder
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
Other adverse events
| Measure |
Neuro-Spinal Scaffold
n=19 participants at risk
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
31.6%
6/19 • Number of events 7 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Cardiac disorders
Cardiac arrest
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Cardiac disorders
Tachycardia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
31.6%
6/19 • Number of events 6 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Anal fissure
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Anal ulcer
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
2/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Ileus
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 5 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Proctitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Tooth impacted
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Adverse drug reaction
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Chest pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Generalised oedema
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Medical device complication
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Non-cardiac chest pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Pyrexia
|
42.1%
8/19 • Number of events 8 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Systemic inflammatory response syndrome
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Immune system disorders
Drug hypersensitivity
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Bacterial infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Candiduria
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Cellulitis
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Clostridium difficile infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Enterococcal infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Fungal skin infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Impetigo
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Localised infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Meningitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Septic shock
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Serratia infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Tinea pedis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Infections and infestations
Urinary tract infection
|
63.2%
12/19 • Number of events 38 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.5%
2/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Injury, poisoning and procedural complications
Wound
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Ammonia increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood prolactin increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood urea increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Body temperature fluctuation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Body temperature increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
C-reactive protein increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Hepatic enzyme increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Red blood cell sedimentation rate increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
White blood cell count increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
5/19 • Number of events 5 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.3%
5/19 • Number of events 7 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
57.9%
11/19 • Number of events 15 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
15.8%
3/19 • Number of events 6 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Necrotising myositis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.3%
5/19 • Number of events 9 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Syringomyelia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Aphasia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Dysaesthesia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Number of events 5 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Migraine
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Muscle spasticity
|
21.1%
4/19 • Number of events 6 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Myelomalacia
|
10.5%
2/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Neuralgia
|
52.6%
10/19 • Number of events 12 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Neurological decompensation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Paraesthesia
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Poor quality sleep
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Spinal meningeal cyst
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Acute stress disorder
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Agitation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Anxiety
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Depression
|
26.3%
5/19 • Number of events 8 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Psychiatric disorders
Mood swings
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Renal and urinary disorders
Bladder pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Renal and urinary disorders
Incontinence
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Renal and urinary disorders
Renal failure acute
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Renal and urinary disorders
Urinary incontinence
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Reproductive system and breast disorders
Genital rash
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Reproductive system and breast disorders
Scrotal pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
21.1%
4/19 • Number of events 5 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
21.1%
4/19 • Number of events 6 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.5%
2/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
26.3%
5/19 • Number of events 7 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Haemorrhage
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Hypotension
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Thrombophlebitis
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Vascular disorders
Venous occlusion
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
General disorders
Injection site pain
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
|
Nervous system disorders
Autonomic dysreflexia
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from the implantation of scaffold through the 6 month primary endpoint follow-up visit from to the 12 month follow-up for the subjects that reached this time point at the time of analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place