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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00737607
First received: August 18, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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
Lumbar Spinal Stenosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Study of Microendoscopic Decompressive Laminotomy for Treatment of Lumbar Spinal Stenosis

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: August 18, 2008
Last Updated: August 18, 2008
Health Authority: Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014