Intermittent Neurogenic Claudication Treatment With APERIUS®

NCT00887744 | Completed Phase 4 Results

• 1 other identifier: CIP-0001-AP
• Study Type: interventional
• Target: 162
• Locations: 3 countries
• Sites: 12

Brief Summary

The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius® device.

Conditions

Spinal Stenosis

Keywords

Degenerative Lumbar Spinal Stenosis; Neurogenic Intermittent Claudication; Interpinous Device; Percutaneous

Outcome Measures

Primary Outcomes (2)

• Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity

  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.

  From baseline up to 6 weeks follow-up

• The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure

  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

  Starting at the surgical procedure till 7 days post-operatively

Secondary Outcomes (4)

• Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity

  From baseline up to 12 months follow up

• Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire

  From baseline up to 12 months

• Mean Change in Quality of Life Score at 12 Months Compared to Baseline

  From baseline up to 12 months follow up

• Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.

  From baseline up to 12 months follow up

Study Arms (1)

Aperius Treatment Arm

OTHER

Single Arm

Device: Aperius® Percutaneous Interspinous Spacer

Interventions

Aperius® Percutaneous Interspinous Spacer DEVICE

Implantation of the Aperius® device

Also known as: Aperius®

Aperius Treatment Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of Degenerative Lumbar Spinal Stenosis (Lumbar spine level from L1 -L5), confirmed by Magnetic Resonance Imaging (MRI) at one or maximal two levels, with symptoms of intermittent neurogenic claudication.
• Leg / Buttock / Groin pain, with or without back pain, relieved by flexion. If back pain is also present, it must be partially relieved when flexed.
• Able to sit for 50 minutes without pain.
• Able to walk a distance of 20 meters without pain.
• Patient states availability for and willing to perform all follow -up examinations.
• Patient signed informed consent form.
• Adults (minimum 21 years of age).

You may not qualify if:

• Previous lumbar surgery.
• Unremitting pain (leg/buttock/groin/back) in any spinal position.
• Axial back pain without leg/buttock/groin pain.
• Significant lumbar instability at the affected level: spondylolisthesis greater than grade 1 on a scale from 1-4.
• Objective motor deficit.
• Significant peripheral neuropathy by nerve conduction velocity tests (peroneal and sural nerves) according to the investigator.
• Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (retention or incontinence).
• Spinal Stenosis with clinical symptoms at one or more levels outside the L1-L5 lumbar region.
• Severe symptomatic Spinal Stenosis requiring immediate surgical decompression,according to the investigator or lumbar spinal stenosis at more than 2 levels.
• Lumbar Spinal Stenosis, caused by tumors, metastasis or Paget's disease.
• Vascular claudication and severe peripheral vascular disease. (Diminished dorsalis pedis or tibial pulses) that limits walking.
• History of primary or secondary osteoporosis defined as a DXA scan (=dual energy x-ray absorptiometry) of the hip showing T-score (=the number of standard deviations above or below the mean for the patient's age, sex and ethnicity) of more than 2.5 standard deviation below the mean in the presence of one or more fragility fractures.
• Active systemic infection or local infection at the level to treat.
• Major Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria.
• Dementia and/or inability to give informed consent.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (12)

Hospital Campus Middelheim

Antwerp, Belgium

Location

Academic Hospital Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

Park Léopold Hospital

Brussels, Belgium

Location

Notre Dame de Grace Hospital

Gosselies, Belgium

Location

University Hospital Tivoli

La Louvière, Belgium

Location

Hospital du Grand Hornu

Mons, Belgium

Location

Klinik und Poliklinik für Orthopädie (Hospital)

Cologne, Germany

Location

Gemeinschaftspraxis Königsallee (Privat Clinic)

Düsseldorf, Germany

Location

University Hospital Erlangen

Erlangen, Germany

Location

Asklepios Hospital Lindenlohe

Schwandorf in Bayern, Germany

Location

Orthopädische Fachklinik Schwarzach (Hospital)

Schwarzach, Germany

Location

Woodend Hospital

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: E. Wülfert, Medical Affairs & Clinical Operations Director
• Organization: Medtronic Spinal & Biologics Europe and Central Asia

inca.studyregistration@medtronic.com

Study Officials

• E. Wuelfert, Pharm.

  Medtronic Spinal & Biologics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: November 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: March 1, 2010
• Last Updated: January 28, 2016
• Results First Posted: August 17, 2011

Record last verified: 2016-01

Locations

DE (5); GB (1); BE (6)