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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Foraminal Stenosis
• Intervention / Treatment: Procedure: TLIF and unilateral pedicle screw fixation; Device: Pedicle screw and cage; Procedure: TLIF and bilateral pedicle screw fixation

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Signed informed consent.
• Patient is willing to be available for each examination scheduled over the study duration.
• Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
• Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
• Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).

Exclusion Criteria:

• Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
• Has presence of active malignancy
• Has a history of severe allergy
• Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
• Pregnant, or may become pregnant within follow-up period of study
• Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
• Spondylolisthesis at the target level
• Has undergone previous lumbar surgery
• Has severe osteoporosis (T-score ≤ -3.5)
• BMI > 35kg/m2
• Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
• Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral fixation; Patients undergoing TLIF and unilateral pedicle screw fixation	Procedure: TLIF and unilateral pedicle screw fixation; TLIF combined with posterior unilateral pedicle screw fixation; Device: Pedicle screw and cage; Pedicle screw and cage
Active Comparator: Bilateral fixation; Patients undergoing TLIF and bilateral pedicle screw fixation	Device: Pedicle screw and cage; Pedicle screw and cage; Procedure: TLIF and bilateral pedicle screw fixation; TLIF combined with posterior bilateral pedicle screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogue Scale (VAS) scores	2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to procedure		2 years postoperatively
Operative duration		1 week postoperatively
Estimated blood loss		1 week postoperatively
Length of hospital stay		1 week after discharge
Spinal angles	Radiographic parameters	2 years postoperatively
Intervertebral space height	Radiographic parameters	2 years postoperatively
Foraminal height	Radiographic parameters	2 years postoperatively
Cost of treatment		2 years postoperatively
Fusion rate		2 years postoperatively
Oswestry Disability Index (ODI)		2 years postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: December 4, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: SNPHO-161116