Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lumbar Spondylolisthesis

Treatments: Procedure: laminectomy with PLIF; Procedure: Bilateral decompression with TLIF; Device: Pedicle screw and interbody cage

Study type: Interventional

Funder types: Other

Identifiers

NCT02972190

SNPHO-161107

Details and patient eligibility

About

Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. lumbar spondylolisthesis
2. symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
3. at least 3 months of failed conservative therapies

Exclusion criteria

1. multilevel lumbar degenerative diseases
2. history of previous lumbar surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Bilateral decompression with TLIF

Experimental group

Description:

Patients undergoing bilateral decompression with TLIF

Treatment:

Device: Pedicle screw and interbody cage

Procedure: Bilateral decompression with TLIF

laminectomy with PLIF

Active Comparator group

Description:

Patients undergoing laminectomy with PLIF

Treatment:

Device: Pedicle screw and interbody cage

Procedure: laminectomy with PLIF