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

Primary Purpose

Lumbar Herniated Disc

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Microdiscectomy
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Herniated Disc

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Winnipeg Spine Research Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Minimally Invasive Microdiscectomy

Conventional Open Microdiscectomy

Arm Description

Outcomes

Primary Outcome Measures

Physical activity monitor

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
August 13, 2011
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00927056
Brief Title
Evaluation of Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For Lumbar Herniated Disc
Official Title
Early Activity Monitoring and Pain Assessment in Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For The Treatment of Lumbar Herniated Disc
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Herniated Disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Microdiscectomy
Arm Type
Active Comparator
Arm Title
Conventional Open Microdiscectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Microdiscectomy
Intervention Description
Minimally invasive microdiscectomy versus conventional open microdiscectomy
Primary Outcome Measure Information:
Title
Physical activity monitor
Time Frame
continuous for 3 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Johnson, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winnipeg Spine Research Lab
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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