NCT02985138

Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2016-12-07
• Last updated: 2022-01-25

Locations

1 site across 1 country: China