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

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ClinicalTrials.gov Identifier: NCT01057641
Recruitment Status : Terminated (low enrollment)
First Posted : January 27, 2010
Last Update Posted : November 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Gregor Stein, University of Cologne

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date November 6, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Changes in subscores for bodily pain and physical function on SF-36 [ Time Frame: baseline, 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) [ Time Frame: baseline, 6 months ]
  • Physical function by applying ZCQ [ Time Frame: baseline, 6 months ]
  • Post-treatment patient satisfaction by applying ZCQ [ Time Frame: baseline, 6 months ]
  • General health status (Quality of life) by applying SF-36 [ Time Frame: baseline, 6 months ]
  • Measurement of walking distance [ Time Frame: baseline, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE
  • Procedure: Spacer
    Implantation of a percutaneously implanted interspinous device (spacer)
    Other Name: PIDLSS
  • Other: physiotherapy
    physiotherapy
    Other Name: PIDLSS
Study Arms  ICMJE
  • Experimental: Spacer
    Implantation of a percutaneously implanted interspinous device ("spacer")
    Intervention: Procedure: Spacer
  • 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.
    Intervention: Other: physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 26, 2010)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057641
Other Study ID Numbers  ICMJE PI-DLSS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Gregor Stein, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Kaulhausen, MD University Hospital of Cologne
PRS Account University of Cologne
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP