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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Gregor Stein, University of Cologne
ClinicalTrials.gov Identifier:
NCT01057641
First received: January 26, 2010
Last updated: February 7, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Changes in subscores for bodily pain and physical function on SF-36 [ Time Frame: baseline, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057641

Contacts
Contact: Thomas Kaulhausen, MD +49 221 47887294 thomas.kaulhausen@uk-koeln.de

Locations
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         
Sponsors and Collaborators
University of Cologne
Investigators
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 July 29, 2014