Evaluation of Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For Lumbar Herniated Disc

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00927056
First received: June 22, 2009
Last updated: August 13, 2011
Last verified: August 2011

June 22, 2009
August 13, 2011
June 2009
June 2012   (final data collection date for primary outcome measure)
Physical activity monitor [ Time Frame: continuous for 3 weeks postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00927056 on ClinicalTrials.gov Archive Site
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Evaluation of Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For Lumbar Herniated Disc
Early Activity Monitoring and Pain Assessment in Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For The Treatment of Lumbar Herniated Disc

Overall Objective: To evaluate pain and functional status of patients undergoing surgical correction for lumbar herniated disc, pre- and post-surgery, using subjective (VAS, Oswestry, PSQI, Patient Expectation), as well as, objective measures of physical activity (triaxial accelerometry).

Design and Methods: Two groups of subjects will be examined; 1) patients diagnosed with lumbar herniated disc undergoing minimally invasive microdiscectomy (MD), and 2) patients diagnosed with lumbar herniated disc undergoing open microlumbar discectomy (OD).

Subjects who agree to participate, will be assessed (assessments listed below) after the diagnosis and prior to surgery. The subject will then be assessed postop and they will continue with follow-up after surgery with a visit at 3 weeks postop. Both methods of discectomy will be discussed with the subject. Once the subject has consented to participate (and prior to surgery), subjects will be randomized with a 50/50 chance of being placed in the MD or OD groups. Subjects will be distributed into the MD group and the OD group using a block randomization method. The study will be single blinded. A longitudinal, within group, comparison will be made to assess the change in the measured parameters. Data involving the MD and OD groups will be accumulated in a cross-sectional fashion.

Subjects will be recruited from the referrals to the practices of the Orthopedic and Neurosurgeon Spine Surgeons at the Health Sciences Centre. This encompasses the majority of new and currently managed cases in the Manitoba and Northwestern Ontario.

Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited into the study. All patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. Imaging (CT) will document single level lumbar herniated nucleus pulposis. Exclusion criteria will be cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury). Subjects participating will be required to speak and read English.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Lumbar Herniated Disc
Procedure: Microdiscectomy
Minimally invasive microdiscectomy versus conventional open microdiscectomy
  • Active Comparator: Minimally Invasive Microdiscectomy
    Intervention: Procedure: Microdiscectomy
  • Active Comparator: Conventional Open Microdiscectomy
    Intervention: Procedure: Microdiscectomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
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June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects will be between the ages of 18 and 90.
  • Male and female subjects will be recruited into the study.
  • All patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. Imaging (CT) will document single level lumbar herniated nucleus pulposis.
  • Subjects participating will be required to speak and read English.

Exclusion Criteria:

  • Cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury).
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00927056
H2006:186
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Dr. Michael Johnson/Principal Investigator, Health Sciences Centre
University of Manitoba
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Principal Investigator: Michael Johnson, MD University of Manitoba
University of Manitoba
August 2011

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