Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT

Hospital for Special Surgery, New York

Overview

This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.

While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. The current study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression. Enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. Operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Patients With Spinal Stenosis Indicated for LLIF

Interventions

One-level lateral lumbar interbody fusion with Indirect DecompressionPROCEDURE

One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.

One-level lateral lumbar interbody fusion with Direct DecompressionPROCEDURE

One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access instruments. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2. Additionally, direct decompression through midline or parasagittal approach will be utilized. A unilateral laminotomy or complete bilateral laminectomy may be performed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons: * Mobile degenerative spondylolisthesis * Severe vertical foraminal stenosis * Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain * One-level central canal stenosis * WITH neurogenic claudication * As measured in preoperative MRI * Oswestry Low Back Pain Disability Questionnaire score \> 35% (18/50) * Failed 3 months of conservative treatment * Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms Exclusion Criteria: * Multilevel central canal stenosis * Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage * Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum * Prior surgery at index disc level (discectomy, decompression, or fusion) * History of spinal or vertebral infection of the lumbar spine * History of vertebral fracture of the lumbar spine * Current pregnancy or interest in becoming pregnant over the next 1 year * Active infection-systemic or local * Non-English speakers

Locations (1)

Hospital for Special Surgery

New York, New York, United States

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

Change in Oswestry Disability Index (ODI) 100 point scale. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools \[1\]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.

Time frame: Up to 12 months post-operatively

Comparison of Oswestry Disability Index (ODI)

Compare ODI scores to assess the kinetics of improvement in the control (direct decompression) vs. treatment (indirect decompression) groups. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools \[1\]. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated by adding all scores for each statement, divided by 50 total possible points, and then multiplied by 100 for a percentage. Percentage scores are interpreted on a scale from 0-20% as minimal disability to 61-100% as crippled.

Time frame: Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)

Secondary Outcomes

Reoperation Rate

Reoperation rate on the lumbar spine within 12 months and within 24 months

Time frame: Within 12 months and 24 months, post-operatively.

Data from ClinicalTrials.gov

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