Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lumbar Spinal Stenosis |
Procedure: Spacer implantation Procedure: physiotherapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Changes in subscores for bodily pain and physical function on SF-36 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- Physical function by applying ZCQ [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- Post-treatment patient satisfaction by applying ZCQ [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- General health status (Quality of life) by applying SF-36 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]
- Measurement of walking distance [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 22 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Spacer
Implantation of a percutaneously implanted interspinous device ("spacer")
|
Procedure: Spacer implantation
Implantation of a percutaneously implanted interspinous device
Other Name: PIDLSS
|
|
No Intervention: 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.
|
Procedure: physiotherapy
physiotherapy
Other Name: PIDLSS
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Thomas Kaulhausen, MD | +49 221 47887294 | thomas.kaulhausen@uk-koeln.de |
| Germany | |
| University Hospital Cologne | Recruiting |
| Cologne, NRW, Germany, 50931 | |
| Contact: Thomas Kaulhausen, Dr. med +49-(0)221-478-87294 thomas.kaulhausen@uk-koeln.de | |
| Principal Investigator: Thomas Kaulhausen, Dr.med | |
| University Hospital of Cologne | Not yet recruiting |
| Cologne, Germany, 50924 | |
| Contact: Thomas Kaulhausen, MD +49 221 478 87294 thomas.kaulhausen@uk-koeln.de | |
| Principal Investigator: Thomas Kaulhausen, Dr.med | |
| Principal Investigator: | Thomas Kaulhausen, MD | University Hospital of Cologne |
More Information
No publications provided
| Responsible Party: | Dr. Gregor Stein, Dr. med, University of Cologne |
| ClinicalTrials.gov Identifier: | NCT01057641 History of Changes |
| Other Study ID Numbers: | PI-DLSS |
| Study First Received: | January 26, 2010 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Cologne:
|
PIDLSS, Spacer |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013