Trial Outcomes & Findings for Intermittent Neurogenic Claudication Treatment With APERIUS® (NCT NCT00887744)
NCT ID: NCT00887744
Last Updated: 2016-01-28
Results Overview
This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
From baseline up to 6 weeks follow-up
Results posted on
2016-01-28
Participant Flow
The first patient entered the study on November 20, 2006 and the last patient's last visit was on May 21, 2009 with a total study duration of 30 months.
Not applicable. Single arm study
Participant milestones
| Measure |
Aperius® Treatment Arm
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
128
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Aperius® Treatment Arm
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Various reasons
|
9
|
Baseline Characteristics
Intermittent Neurogenic Claudication Treatment With APERIUS®
Baseline characteristics by cohort
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 6 weeks follow-upPopulation: Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.
This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Outcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
|
-29.7 Percent change
Standard Deviation 23.4
|
PRIMARY outcome
Timeframe: Starting at the surgical procedure till 7 days post-operativelyAdverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed: * Day of the procedure until P+1 (where P refers to the day of the surgical procedure) * P+2 until P+7
Outcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
|
3.8 Proportion of patients (%)
|
SECONDARY outcome
Timeframe: From baseline up to 12 months follow upThe Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Outcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
|
26.7 Percent Change
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: From baseline up to 12 monthsThe Zurich Claudication Questionnaire - Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0. The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.
Outcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
|
25.3 Percent Change
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: From baseline up to 12 months follow upThe quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.
Outcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Mean Change in Quality of Life Score at 12 Months Compared to Baseline
|
30 Scores on a scale (1-100)
Standard Deviation 31
|
SECONDARY outcome
Timeframe: From baseline up to 12 months follow upOutcome measures
| Measure |
Aperius® Treatment Arm
n=157 Participants
The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
|
|---|---|
|
Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
|
7.6 Proportion of patients (%)
|
Adverse Events
ITT Analysis
Serious events: 39 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ITT Analysis
n=157 participants at risk
Single group - Aperius
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Arrhythmia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
6/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
6/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Cardiac disorder
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Cerebrovascular accident
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Psychiatric disorders
Depression
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Dizziness
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Generalised oedema
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Vascular disorders
Haematoma
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Lower respiratory tract infection
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Psychiatric disorders
Major depression
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal pain
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Peritonitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Pneumonia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Renal and urinary disorders
Renal aneurysm
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Sciatica
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Social circumstances
Social stay hospitalization
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Spinal claudication
|
3.8%
6/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
Other adverse events
| Measure |
ITT Analysis
n=157 participants at risk
Single group - Aperius
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Angina Pectoris
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
13/157 • Number of events 14 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Ataxia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.5%
40/157 • Number of events 47 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Bone erosion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Bradycardia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Bronchitis
|
3.8%
6/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
1/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Contusion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Cystisis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Psychiatric disorders
Depressed mood
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Diverticulitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Dizziness
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Eye disorders
Eye inflammation
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Metabolism and nutrition disorders
Gout
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.5%
7/157 • Number of events 8 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Vascular disorders
Haematoma
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Headache
|
2.5%
4/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Herpes Zoster
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Hypoesthesia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Endocrine disorders
Hypogonadism
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Implant site swelling
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Incision site pain
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Inflammation
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Influenza
|
2.5%
4/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Influenza like illness
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Intervertbral disc disorder
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Laryngitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Investigations
Liver function test abnormal
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
2.5%
4/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Vascular disorders
Lymphoedema
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Psychiatric disorders
Mental disorder
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Migraine
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.9%
3/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.6%
26/157 • Number of events 32 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Hepatobiliary disorders
Nausea
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Psychiatric disorders
Nerve root lesion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Neuralgia
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Hepatobiliary disorders
Oedema peripheral
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Oral herpes
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.5%
7/157 • Number of events 10 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Pain
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.8%
28/157 • Number of events 31 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Paraesthesia
|
3.8%
6/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
2.5%
4/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
General disorders
Pyrexia
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Radiation exposure
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Renal and urinary disorders
Renal cyst
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Rhinitis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Sciatica
|
3.2%
5/157 • Number of events 6 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Sensorimotor disorder
|
0.64%
1/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Sensory disturbance
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
1.3%
2/157 • Number of events 2 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Spinal claudication
|
15.9%
25/157 • Number of events 26 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.9%
3/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Syncope
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Nervous system disorders
Syncope vasovagal
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
4/157 • Number of events 4 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
3/157 • Number of events 3 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.64%
1/157 • Number of events 1 • All Adverse events were gathered as from the moment the first patient entered the study on November 20, 2006 until the last patient's completed the last visit on May 21, 2009 with a total study duration of 30 months.
All serious adverse device effects are listed below
|
Additional Information
E. Wülfert, Medical Affairs & Clinical Operations Director
Medtronic Spinal & Biologics Europe and Central Asia
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator acknowledge that all information affecting or relating to Sponsor's products that is developed, discovered, or transmitted in connection with the study, including the multi-center data resulting from the study and any inventions or moral rights, shall belong to Sponsor, and nothing shall be construed to confer upon or grant to Institution or Investigator any right, title, or interest therein.
- Publication restrictions are in place
Restriction type: OTHER