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Clinical Outcome Study of Minimally Invasive Decompression for Lumbar Spinal Stenosis (MEDLLSS)

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ClinicalTrials.gov Identifier: NCT00737607
Recruitment Status : Unknown
Verified August 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 19, 2008
Last Update Posted : August 19, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

The study is a prospective outcome study to evaluate the effectiveness and treatment outcomes of microendoscopic decompressive laminotomy (MEDL) with objective evaluation tools. The patients who fulfill the selection criteria will be enrolled to collect the pre-operative clinical data including demographic data, image studies, and functional evaluation for neurological symptoms and disability.

The patient will receive MEDL and post-operative follow-up will be arranged at 1 week, 1 month, 6 months, and 12 months after the operation. All the collected data will be analyzed to evaluate the efficacy and treatment results of MEDL.


Condition or disease
Lumbar Spinal Stenosis

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Study of Microendoscopic Decompressive Laminotomy for Treatment of Lumbar Spinal Stenosis
Study Start Date : January 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients with degenerative lumbar spinal stenosis who failed conservative treatment.
Criteria

Inclusion Criteria:

  • neurogenic claudication or radicular leg pain with associated neurologic signs referring to the LSS syndrome
  • moderate to severe spinal canal stenosis shown on cross-sectional imaging such as MRI or CT scan
  • failure of conservative treatment for at least three months

Exclusion Criteria:

  • mechanical low back pain or segmental instability
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737607


Contacts
Contact: Jwo-Luen Pao, MD +886-2-89667000 ext 2314 drpao@yahoo.com
Contact: Shih-Hurng Huang, MD, PhD +886-2-89667000 ext 2152 irb@mail.femh.org.tw

Locations
Taiwan
Far-Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Jwo-Luen Pao, MD    +886-2-89667000 ext 2314    drpao@yahoo.com   
Contact: Shih-Horng Huang, MD, PhD    +886-2-89667000 ext 2512    irb@mail.femh,org.tw   
Principal Investigator: Jwo-Luen Pao, MD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Jwo-Luen Pao, MD Far-Eastern Memorial Hospital, Taipei, Taiwan
More Information

Responsible Party: Jwo-Luen Pao, Far-Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00737607     History of Changes
Other Study ID Numbers: 97034
FEMH-96-C-039
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: August 19, 2008
Last Verified: August 2008

Keywords provided by Far Eastern Memorial Hospital:
outcome
surgery
lumbar spinal stenosis
minimally invasive

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases