Clinical trial NCT04708977: Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT
Official title: Is Indirect Decompression Sufficient for the Treatment of Central Stenosis?: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patients With Spinal Stenosis Indicated for LLIF
Keywords: Lateral Lumbar Interbody Fusion (LLIF)
Foraminal Stenosis
Spine Fusion
Decompression
Lumbar
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Up to 12 months post-operatively
measure: Comparison of Oswestry Disability Index (ODI)
timeFrame: Up to 24 months post-operatively. (6 weeks, 3, 6, 12, and 24 months timepoints)
Secondary outcomes:
measure: Reoperation Rate
timeFrame: Within 12 months and 24 months, post-operatively.
measure: Complication Rate
timeFrame: Within 12 months and 24 months, post-operatively.
measure: Numeric Rated Scale (NRS)-Back and Leg pain
timeFrame: 6- Weeks, 3-, 6-, 12-, and 24-Months.
measure: Radiographic Measurements - Lumbar Lordosis
timeFrame: Preoperative and 12-Month radiographs
measure: Radiographic Measurements - Segmental Lordosis
timeFrame: Preoperative and 12-Month radiographs
measure: Radiographic Measurements - Disc Space Height
timeFrame: Preoperative and 12-Month radiographs
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Sravisht Iyer, MD
role: PRINCIPAL_INVESTIGATOR
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