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

Hospital for Special Surgery (HSS)

Status

Withdrawn

Conditions

Patients With Spinal Stenosis Indicated for LLIF

Treatments

Procedure: One-level lateral lumbar interbody fusion with Indirect Decompression

Procedure: One-level lateral lumbar interbody fusion with Direct Decompression

Study type

Interventional

Funder types

Other

Identifiers

NCT04708977

2019-2228

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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