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

October 4, 2021 updated by: Hospital for Special Surgery, New York

Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1: Indirect Decompression
Lateral lumbar interbody fusion (LLIF), with indirect decompression
Procedure: One-level lateral lumbar interbody fusion with Indirect Decompression
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.
ACTIVE_COMPARATOR: Group 2: Direct Decompression
Lateral lumbar interbody fusion (LLIF), with direct decompression
Procedure: One-level lateral lumbar interbody fusion with Direct Decompression

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: 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.
Up to 12 months post-operatively
Comparison of Oswestry Disability Index (ODI)
Time Frame: 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.
Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation Rate
Time Frame: Within 12 months and 24 months, post-operatively.
Reoperation rate on the lumbar spine within 12 months and within 24 months
Within 12 months and 24 months, post-operatively.
Complication Rate
Time Frame: Within 12 months and 24 months, post-operatively.
Complication rate within 12 months and within 24 months
Within 12 months and 24 months, post-operatively.
Numeric Rated Scale (NRS)-Back and Leg pain
Time Frame: 6- Weeks, 3-, 6-, 12-, and 24-Months.
Patient Reported Outcomes: Numeric Rated Scale (NRS)-back and leg pain scores
6- Weeks, 3-, 6-, 12-, and 24-Months.
Radiographic Measurements - Lumbar Lordosis
Time Frame: 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.
Preoperative and 12-Month radiographs
Radiographic Measurements - Segmental Lordosis
Time Frame: 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.
Preoperative and 12-Month radiographs
Radiographic Measurements - Disc Space Height
Time Frame: 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.
Preoperative and 12-Month radiographs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Sravisht Iyer, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2021

Primary Completion (ACTUAL)

September 29, 2021

Study Completion (ACTUAL)

September 29, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-2228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only the PI, study coordinators listed on the IRB protocol, and co-investigators will have access to the IPD information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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