Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis

November 24, 2016 updated by: Xiaofei Cheng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200011
        • Recruiting
        • Department of Orthopedic Surgery, Shanghai Ninth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bilateral decompression with TLIF
Patients undergoing bilateral decompression with TLIF
Procedure: Bilateral decompression with TLIF
Bilateral decompression of neural elements combined with TLIF
Device: Pedicle screw and interbody cage
Pedicle screw and interbody cage
ACTIVE_COMPARATOR: laminectomy with PLIF
Patients undergoing laminectomy with PLIF
Device: Pedicle screw and interbody cage
Pedicle screw and interbody cage
Procedure: laminectomy with PLIF
Decompression of neural elements using laminectomy combined with PLIF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (ESTIMATE)

November 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 24, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNPHO-161107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Spondylolisthesis

Clinical Trials on Bilateral decompression with TLIF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe