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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Herniated Disc
• Intervention / Treatment: Procedure: Microdiscectomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg Spine Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Minimally Invasive Microdiscectomy	Procedure: Microdiscectomy; Minimally invasive microdiscectomy versus conventional open microdiscectomy
Active Comparator: Conventional Open Microdiscectomy	Procedure: Microdiscectomy; Minimally invasive microdiscectomy versus conventional open microdiscectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical activity monitor	continuous for 3 weeks postoperatively

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Michael Johnson, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: June 22, 2009
• First Submitted That Met QC Criteria: June 23, 2009
• First Posted (Estimate): June 24, 2009

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 13, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: H2006:186