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Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

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StatusTerminated
Sponsors
University of Cologne

Keywords

Abstract

Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

Dates

Last Verified: 10/31/2016
First Submitted: 01/25/2010
Estimated Enrollment Submitted: 01/25/2010
First Posted: 01/26/2010
Last Update Submitted: 11/03/2016
Last Update Posted: 11/06/2016
Actual Study Start Date: 02/28/2011
Estimated Primary Completion Date: 04/30/2016
Estimated Study Completion Date: 05/31/2018

Condition or disease

Lumbar Spinal Stenosis

Intervention/treatment

Procedure: Spacer

Other: physiotherapy

Phase

Phase 4

Arm Groups

ArmIntervention/treatment
Experimental: Spacer
Implantation of a percutaneously implanted interspinous device ("spacer")
Procedure: Spacer
Implantation of a percutaneously implanted interspinous device (spacer)
Other: physiotherapy
The control group will receive at least physiotherapy and physical therapy (e.g. massage and fango). Under inpatient conditions therapy will last for seven days. After discharge physical therapy has to be continued for 5 weeks. A schedule will ensure the consistency of the physical therapy. The inpatient-treatment can be repeated every 6 months if necessary.
Other: physiotherapy
physiotherapy

Eligibility Criteria

Ages Eligible for Study 50 Years To 50 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

1. Male or female over 50 years of age

2. One, two, or three segment degenerative lumbar spinal stenosis (DLSS)

3. Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit

4. Pain relief in inclination or sitting

5. Ability to walk over a distance of 50 m

6. Unsuccessful conservative therapy for 3 months under outpatient conditions

7. Informed consent

Exclusion Criteria:

1. Fixed motoric deficit

2. Cauda equina syndrome

3. Previous surgery of the lumbar spine

4. Severe osteoporosis of the vertebrae and/or of the hip

5. Spondylolisthesis more severe than Meyerding I (on scale of I-IV)

6. Metastasis of the vertebrae

7. Mentally disabled persons

Outcome

Primary Outcome Measures

1. Changes in subscores for bodily pain and physical function on SF-36 [baseline, 6 months]

Secondary Outcome Measures

1. Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) [baseline, 6 months]

2. Physical function by applying ZCQ [baseline, 6 months]

3. Post-treatment patient satisfaction by applying ZCQ [baseline, 6 months]

4. General health status (Quality of life) by applying SF-36 [baseline, 6 months]

5. Measurement of walking distance [baseline, 6 months]

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