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Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

NCT ID: NCT02972190

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Lumbar Spondylolisthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bilateral decompression with TLIF

Patients undergoing bilateral decompression with TLIF

Group Type EXPERIMENTAL

Bilateral decompression with TLIF

Intervention Type PROCEDURE

Bilateral decompression of neural elements combined with TLIF

Pedicle screw and interbody cage

Intervention Type DEVICE

Pedicle screw and interbody cage

laminectomy with PLIF

Patients undergoing laminectomy with PLIF

Group Type ACTIVE_COMPARATOR

laminectomy with PLIF

Intervention Type PROCEDURE

Decompression of neural elements using laminectomy combined with PLIF

Pedicle screw and interbody cage

Intervention Type DEVICE

Pedicle screw and interbody cage

Interventions

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Bilateral decompression with TLIF

Bilateral decompression of neural elements combined with TLIF

Intervention Type PROCEDURE

laminectomy with PLIF

Decompression of neural elements using laminectomy combined with PLIF

Intervention Type PROCEDURE

Pedicle screw and interbody cage

Pedicle screw and interbody cage

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Xiaofei Cheng

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofei Cheng, MD

Role: CONTACT

Phone: 8613917556604

Email: [email protected]

Facility Contacts

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Xiaofei Cheng, MD

Role: primary

Other Identifiers

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SNPHO-161107

Identifier Type: -

Identifier Source: org_study_id