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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04708977
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospital for Special Surgery, New York
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sravisht Iyer, MD
Principal Investigator Affiliation	Hospital for Special Surgery, New York
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Patients With Spinal Stenosis Indicated for LLIF

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Group 1: Indirect Decompression

Lateral lumbar interbody fusion (LLIF), with indirect decompression

Active Comparator: Group 2: Direct Decompression

Lateral lumbar interbody fusion (LLIF), with direct decompression

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hospital for Special Surgery, New York, New York

Status

Address

Hospital for Special Surgery

New York, New York, 10021

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