NCT04708977

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Spinal Stenosis Indicated for LLIF

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-08
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2021-01-14
• Last updated: 2021-10-11

Locations

1 site across 1 country: United States