Clinical trial NCT01057641: Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lumbar Spinal Stenosis
Keywords: PIDLSS, Spacer
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Changes in subscores for bodily pain and physical function on SF-36
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)
timeFrame: baseline, 6 months
measure: Physical function by applying ZCQ
timeFrame: baseline, 6 months
measure: Post-treatment patient satisfaction by applying ZCQ
timeFrame: baseline, 6 months
measure: General health status (Quality of life) by applying SF-36
timeFrame: baseline, 6 months
measure: Measurement of walking distance
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Thomas Kaulhausen, MD
role: PRINCIPAL_INVESTIGATOR
References: