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

NCT ID: NCT00927056

Last Updated: 2011-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

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.

Conditions

Lumbar Herniated Disc

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Minimally Invasive Microdiscectomy

Group Type: ACTIVE_COMPARATOR

Microdiscectomy

Intervention Type: PROCEDURE

Minimally invasive microdiscectomy versus conventional open microdiscectomy

Conventional Open Microdiscectomy

Group Type: ACTIVE_COMPARATOR

Microdiscectomy

Intervention Type: PROCEDURE

Minimally invasive microdiscectomy versus conventional open microdiscectomy

Interventions

Microdiscectomy

Minimally invasive microdiscectomy versus conventional open microdiscectomy

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Health Sciences Centre

Principal Investigators

Michael Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Winnipeg Spine Research Lab

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2006:186

Identifier Type: -

Identifier Source: org_study_id