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

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant in Comparison With the Best Non-operative Treatment of Lumbar Spine Stenosis

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Spacer
* Other: physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 50 years of age One, two, or three segment degenerative lumbar spinal stenosis (DLSS) Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit Pain relief in inclination or sitting Ability to walk over a distance of 50 m Unsuccessful conservative therapy for 3 months under outpatient conditions Informed consent Exclusion Criteria: Fixed motoric deficit Cauda equina syndrome Previous surgery of the lumbar spine Severe osteoporosis of the vertebrae and/or of the hip Spondylolisthesis more severe than Meyerding I (on scale of I-IV) Metastasis of the vertebrae Mentally disabled persons

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spacer<br>Implantation of a percutaneously implanted interspinous device (spacer) | Procedure: Spacer<br>* Implantation of a percutaneously implanted interspinous device (spacer)<br>* Other names: PIDLSS;|
| Other: physiotherapy<br>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<br>* physiotherapy<br>* Other names: PIDLSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subscores for bodily pain and physical function on SF-36 |  | baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) |  | baseline, 6 months | 
| Physical function by applying ZCQ |  | baseline, 6 months | 
| Post-treatment patient satisfaction by applying ZCQ |  | baseline, 6 months | 
| General health status (Quality of life) by applying SF-36 |  | baseline, 6 months | 
| Measurement of walking distance |  | baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PIDLSS, Spacer