Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

Not Applicable

• Conditions: Lumbar Spondylolisthesis
• Interventions: Procedure: Bilateral decompression with TLIF; Procedure: laminectomy with PLIF; Device: Pedicle screw and interbody cage

• Registration Number: NCT02972190
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2016-11-28
• Primary Completion: 2018-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral decompression with TLIF	Bilateral decompression with TLIF	Patients undergoing bilateral decompression with TLIF
Bilateral decompression with TLIF	Pedicle screw and interbody cage	Patients undergoing bilateral decompression with TLIF
laminectomy with PLIF	Pedicle screw and interbody cage	Patients undergoing laminectomy with PLIF
laminectomy with PLIF	laminectomy with PLIF	Patients undergoing laminectomy with PLIF

Primary Outcome Measures

Name	Time	Method
visual analog scale for low back pain and leg pain	2 years postoperatively
Oswestry disability index	2 years postoperatively
Zurich claudication questionnaire	2 years postoperatively
SF-36 score	2 years postoperatively
Fusion rate	2 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Surgery procedure duration	Intraoperation
Estimated blood loss	Intraoperation
Length of postoperative hospital stay	1 week after hospital discharge
Complication	2 years postoperatively
Degree of spondylolisthesis measured by X ray	2 years postoperatively
Disc space height measured by X ray	2 years postoperatively
Lumbar lordosis measured by X ray	2 years postoperatively

Trial Locations

Locations (1)

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China