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

NCT00927056 | Unknown

• 1 other identifier: H2006:186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Physical activity monitor

  continuous for 3 weeks postoperatively

Study Arms (2)

Minimally Invasive Microdiscectomy

ACTIVE COMPARATOR

Procedure: Microdiscectomy

Conventional Open Microdiscectomy

ACTIVE COMPARATOR

Procedure: Microdiscectomy

Interventions

Microdiscectomy PROCEDURE

Minimally invasive microdiscectomy versus conventional open microdiscectomy

Conventional Open Microdiscectomy; Minimally Invasive Microdiscectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Winnipeg Spine Research Lab

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Johnson, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

CA (1)