Greenwich Lumbar Stenosis SLIP Study

Greenwich Hospital

Status and phase: Completed; Phase 3

Conditions: Spondylolisthesis; Spinal Stenosis

Treatments: Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion; Procedure: Lumbar Laminectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00109213

GH-SLIP-384

Details and patient eligibility

About

The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.

Full description

There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.

Enrollment: 66 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)

Exclusion criteria

• History of previous lumbar spinal surgery in region of stenosis
• Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)
• Serious medical illness (ASA Class III or higher)
• Spondylolisthesis greater than 14 mm or associated with spondylolysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

1

Active Comparator group

Description:

Lumbar Laminectomy without Fusion

Treatment:

Procedure: Lumbar Laminectomy

2

Active Comparator group

Description:

Lumbar Laminectomy with Pedicle Screw Instrumented Fusion

Treatment:

Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion