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Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

NCT02985138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-01-25

No results posted yet for this study

Summary

TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.

Conditions

  • Lumbar Foraminal Stenosis

Interventions

PROCEDURE

TLIF and unilateral pedicle screw fixation

TLIF combined with posterior unilateral pedicle screw fixation

PROCEDURE

TLIF and bilateral pedicle screw fixation

TLIF combined with posterior bilateral pedicle screw fixation

DEVICE

Pedicle screw and cage

Pedicle screw and cage

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985138 on ClinicalTrials.gov