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

NCT04708977 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-11

No results posted yet for this study

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.

Conditions

  • Patients With Spinal Stenosis Indicated for LLIF

Interventions

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.

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.

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Sravisht Iyer, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2021-09-29
Completion
2021-09-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04708977 on ClinicalTrials.gov