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

Not Applicable

Withdrawn

• Conditions: Patients With Spinal Stenosis Indicated for LLIF
• Interventions: Procedure: One-level lateral lumbar interbody fusion with Direct Decompression; Procedure: One-level lateral lumbar interbody fusion with Indirect Decompression

• Registration Number: NCT04708977
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-02-08
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Direct Decompression	One-level lateral lumbar interbody fusion with Direct Decompression	Lateral lumbar interbody fusion (LLIF), with direct decompression
Group 1: Indirect Decompression	One-level lateral lumbar interbody fusion with Indirect Decompression	Lateral lumbar interbody fusion (LLIF), with indirect decompression

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Up to 12 months post-operatively	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.
Comparison of Oswestry Disability Index (ODI)	Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)	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.

Secondary Outcome Measures

Name	Time	Method
Complication Rate	Within 12 months and 24 months, post-operatively.	Complication rate within 12 months and within 24 months
Radiographic Measurements - Lumbar Lordosis	Preoperative and 12-Month radiographs	Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in lumbar lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.
Reoperation Rate	Within 12 months and 24 months, post-operatively.	Reoperation rate on the lumbar spine within 12 months and within 24 months
Numeric Rated Scale (NRS)-Back and Leg pain	6- Weeks, 3-, 6-, 12-, and 24-Months.	Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores
Radiographic Measurements - Segmental Lordosis	Preoperative and 12-Month radiographs	Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in segmental lordosis as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.
Radiographic Measurements - Disc Space Height	Preoperative and 12-Month radiographs	Radiographic measurements at 12 months will be compared to preoperative measurements to quantify the change in disc space height as a result of Lateral Lumbar Interbody Fusion (LLIF). Measurements will be taken in millimeters by (2) co-investigators.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States