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Intermittent Neurogenic Claudication Treatment With APERIUS® (INCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00887744
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : August 17, 2011
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spinal Stenosis
Intervention Device: Aperius® Percutaneous Interspinous Spacer
Enrollment 162
Recruitment Details 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.
Pre-assignment Details Not applicable. Single arm study
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 162 [1]
Completed 128
Not Completed 34
Reason Not Completed
Adverse Event             3
Death             1
Lost to Follow-up             3
Withdrawal by Subject             18
Various reasons             9
[1]
162 patients signed an informed consent but only 157 patients were treated with the Aperius.
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants
65  (11.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants
Female
78
  49.7%
Male
79
  50.3%
1.Primary Outcome
Title Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Hide Description 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.
Time Frame From baseline up to 6 weeks follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent change
-29.7  (23.4)
2.Primary Outcome
Title The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure
Hide Description

Adverse 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
Time Frame Starting at the surgical procedure till 7 days post-operatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Proportion of patients (%)
3.8
3.Secondary Outcome
Title Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity
Hide Description

The 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.

Time Frame From baseline up to 12 months follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent Change
26.7  (25.8)
4.Secondary Outcome
Title Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire
Hide Description

The 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.

Time Frame From baseline up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Percent Change
25.3  (27.7)
5.Secondary Outcome
Title Mean Change in Quality of Life Score at 12 Months Compared to Baseline
Hide Description The 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.
Time Frame From baseline up to 12 months follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Mean (Standard Deviation)
Unit of Measure: Scores on a scale (1-100)
30  (31)
6.Secondary Outcome
Title Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.
Hide Description [Not Specified]
Time Frame From baseline up to 12 months follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aperius® Treatment Arm
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Proportion of patients (%)
7.6
Time Frame 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.
Adverse Event Reporting Description All serious adverse device effects are listed below
 
Arm/Group Title ITT Analysis
Hide Arm/Group Description Single group - Aperius
All-Cause Mortality
ITT Analysis
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ITT Analysis
Affected / at Risk (%) # Events
Total   39/157 (24.84%)    
Cardiac disorders   
Arrhythmia * 2  1/157 (0.64%)  1
Atrial fibrillation * 2  1/157 (0.64%)  1
Cardiac disorder * 2  2/157 (1.27%)  2
Gastrointestinal disorders   
Gastric ulcer haemorrhage * 2  1/157 (0.64%)  1
Peritonitis * 2  1/157 (0.64%)  1
Small intestinal obstruction * 2  1/157 (0.64%)  1
General disorders   
Generalised oedema * 2 [1]  1/157 (0.64%)  1
Hepatobiliary disorders   
Cholecystocholangitis * 2  1/157 (0.64%)  1
Infections and infestations   
Lower respiratory tract infection * 2  1/157 (0.64%)  1
Pneumonia * 2  1/157 (0.64%)  1
Injury, poisoning and procedural complications   
Lumbar vertebral fracture * 2  1/157 (0.64%)  1
Meniscus lesion * 2  2/157 (1.27%)  2
Spinal compression fracture * 2  1/157 (0.64%)  1
Spinal fracture * 2  2/157 (1.27%)  2
Metabolism and nutrition disorders   
Hyperglycaemia * 2  1/157 (0.64%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 2  6/157 (3.82%)  6
Back pain * 2  6/157 (3.82%)  6
Bursitis * 2  1/157 (0.64%)  1
Groin pain * 2  1/157 (0.64%)  1
Lumbar spinal stenosis * 2  3/157 (1.91%)  3
Muskuloskeletal pain * 2  1/157 (0.64%)  1
Osteoarthritis * 2  2/157 (1.27%)  2
Pain in extremity * 2  3/157 (1.91%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Abdominal neoplasm * 1  1/157 (0.64%)  1
Hepatic Neoplasm Malignant * 2  1/157 (0.64%)  1
Oesophageal carcinoma * 2  2/157 (1.27%)  2
Nervous system disorders   
Amyotrophic Lateral Sclerosis * 1  1/157 (0.64%)  1
Cerebral artery thrombosis * 2  1/157 (0.64%)  1
Cerebral haemorrhage * 2  1/157 (0.64%)  1
Cerebrovascular accident * 2  1/157 (0.64%)  1
Dizziness * 2  1/157 (0.64%)  1
Sciatica * 2  1/157 (0.64%)  1
Spinal claudication * 2  6/157 (3.82%)  6
Psychiatric disorders   
Depression * 2  1/157 (0.64%)  1
Major depression * 2  1/157 (0.64%)  1
Renal and urinary disorders   
Diabetic nephropathy * 2  1/157 (0.64%)  1
Renal aneurysm * 2  1/157 (0.64%)  1
Respiratory, thoracic and mediastinal disorders   
Apnoea * 2  1/157 (0.64%)  1
Dyspnoea * 2  2/157 (1.27%)  2
Pulmonary embolism * 2  2/157 (1.27%)  2
Social circumstances   
Social stay hospitalization * 2  3/157 (1.91%)  3
Vascular disorders   
Haematoma * 2  1/157 (0.64%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, Medra 10.0
[1]
Administrative site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ITT Analysis
Affected / at Risk (%) # Events
Total   95/157 (60.51%)    
Cardiac disorders   
Angina Pectoris * 1  1/157 (0.64%)  1
Bradycardia * 1  1/157 (0.64%)  1
Myocardial Ischaemia * 1  1/157 (0.64%)  1
Endocrine disorders   
Hypogonadism * 1  1/157 (0.64%)  1
Eye disorders   
Eye inflammation * 1  1/157 (0.64%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/157 (0.64%)  1
Abdominal pain upper * 1  1/157 (0.64%)  1
Constipation * 1  1/157 (0.64%)  2
Faecal incontinence * 1  1/157 (0.64%)  1
Irritable bowel syndrome * 1  1/157 (0.64%)  1
Vomiting * 1  3/157 (1.91%)  3
General disorders   
Implant site swelling * 1 [1]  1/157 (0.64%)  1
Inflammation * 1 [2]  1/157 (0.64%)  1
Influenza like illness * 1 [1]  2/157 (1.27%)  2
Pain * 1 [1]  1/157 (0.64%)  1
Pyrexia * 1 [1]  3/157 (1.91%)  3
Hepatobiliary disorders   
Nausea * 1  2/157 (1.27%)  2
Oedema peripheral * 1 [3]  1/157 (0.64%)  1
Infections and infestations   
Bronchitis * 1  6/157 (3.82%)  6
Cystisis * 1  1/157 (0.64%)  1
Diverticulitis * 1  1/157 (0.64%)  1
Gastroenteritis * 1  1/157 (0.64%)  1
Herpes Zoster * 1  1/157 (0.64%)  1
Influenza * 1  4/157 (2.55%)  4
Laryngitis * 1  1/157 (0.64%)  1
Oral herpes * 1  2/157 (1.27%)  2
Rhinitis * 1  1/157 (0.64%)  1
Urinary tract infection * 1  1/157 (0.64%)  1
Injury, poisoning and procedural complications   
Contusion * 1  1/157 (0.64%)  1
Incision site complication * 1  1/157 (0.64%)  1
Incision site haemorrhage * 1  1/157 (0.64%)  1
Incision site pain * 1  2/157 (1.27%)  2
Limb injury * 1  1/157 (0.64%)  1
Post procedural haemorrhage * 1  1/157 (0.64%)  1
Post-traumatic pain * 1  4/157 (2.55%)  4
Procedural nausea * 1  1/157 (0.64%)  1
Radiation exposure * 1  1/157 (0.64%)  1
Rib fracture * 1  2/157 (1.27%)  2
Skeletal injury * 1  2/157 (1.27%)  2
Skin laceration * 1  1/157 (0.64%)  1
Spinal fracture * 1  3/157 (1.91%)  4
Tendon injury * 1  1/157 (0.64%)  1
Wound complication * 1  1/157 (0.64%)  1
Investigations   
Liver function test abnormal * 1  2/157 (1.27%)  2
Metabolism and nutrition disorders   
Gout * 1  1/157 (0.64%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  13/157 (8.28%)  14
Back pain * 1  40/157 (25.48%)  47
Bone erosion * 1  1/157 (0.64%)  1
Bone lesion * 1  1/157 (0.64%)  1
Cervical spinal stenosis * 1  1/157 (0.64%)  1
Fibromyalgia * 1  1/157 (0.64%)  1
Groin pain * 1  7/157 (4.46%)  8
Intervertbral disc disorder * 1  1/157 (0.64%)  1
Joint effusion * 1  1/157 (0.64%)  1
Joint stiffness * 1  1/157 (0.64%)  1
Joint swelling * 1  1/157 (0.64%)  1
Lumbar spinal stenosis * 1  4/157 (2.55%)  4
Muscular weakness * 1  1/157 (0.64%)  1
Musculoskeletal discomfort * 1  3/157 (1.91%)  4
Musculoskeletal pain * 1  26/157 (16.56%)  32
Myalgia * 1  2/157 (1.27%)  2
Neck pain * 1  2/157 (1.27%)  2
Osteitis * 1  3/157 (1.91%)  3
Osteoarthritis * 1  7/157 (4.46%)  10
Osteochondrosis * 1  1/157 (0.64%)  1
Pain in extremity * 1  28/157 (17.83%)  31
Scoliosis * 1  1/157 (0.64%)  1
Sensation of heaviness * 1  1/157 (0.64%)  1
Spinal osteoarthritis * 1  1/157 (0.64%)  1
Synovial cyst * 1  1/157 (0.64%)  1
Nervous system disorders   
Ataxia * 1  1/157 (0.64%)  1
Carpal tunnel syndrome * 1  1/157 (0.64%)  1
Dizziness * 1  1/157 (0.64%)  1
Headache * 1  4/157 (2.55%)  4
Hypoesthesia * 1  1/157 (0.64%)  1
Migraine * 1  1/157 (0.64%)  1
Neuralgia * 1  2/157 (1.27%)  2
Paraesthesia * 1  6/157 (3.82%)  6
Peripheral nerve lesion * 1  1/157 (0.64%)  1
Sciatica * 1  5/157 (3.18%)  6
Sensorimotor disorder * 1  1/157 (0.64%)  2
Sensory disturbance * 1  3/157 (1.91%)  3
Spinal claudication * 1  25/157 (15.92%)  26
Syncope * 1  1/157 (0.64%)  1
Syncope vasovagal * 1  1/157 (0.64%)  1
Psychiatric disorders   
Depressed mood * 1  1/157 (0.64%)  1
Mental disorder * 1  1/157 (0.64%)  1
Nerve root lesion * 1  1/157 (0.64%)  1
Renal and urinary disorders   
Renal cyst * 1  1/157 (0.64%)  1
Urinary incontinence * 1  4/157 (2.55%)  4
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  1/157 (0.64%)  2
Pharyngolaryngeal pain * 1  3/157 (1.91%)  3
Wheezing * 1  1/157 (0.64%)  1
Skin and subcutaneous tissue disorders   
Ecchymosis * 1  1/157 (0.64%)  1
Vascular disorders   
Haematoma * 1  2/157 (1.27%)  2
Lymphoedema * 1  1/157 (0.64%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Medra 10.0
[1]
Administration site conditions
[2]
Administrative site conditions
[3]
and administration site conditions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: E. Wülfert, Medical Affairs & Clinical Operations Director
Organization: Medtronic Spinal & Biologics Europe and Central Asia
EMail: inca.studyregistration@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00887744     History of Changes
Other Study ID Numbers: CIP-0001-AP
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: April 11, 2011
Results First Posted: August 17, 2011
Last Update Posted: January 28, 2016