Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

NCT ID: NCT02985138

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unilateral fixation

Patients undergoing TLIF and unilateral pedicle screw fixation

Group Type: EXPERIMENTAL

TLIF and unilateral pedicle screw fixation

Intervention Type: PROCEDURE

TLIF combined with posterior unilateral pedicle screw fixation

Pedicle screw and cage

Intervention Type: DEVICE

Pedicle screw and cage

Bilateral fixation

Patients undergoing TLIF and bilateral pedicle screw fixation

Group Type: ACTIVE_COMPARATOR

TLIF and bilateral pedicle screw fixation

Intervention Type: PROCEDURE

TLIF combined with posterior bilateral pedicle screw fixation

Pedicle screw and cage

Intervention Type: DEVICE

Pedicle screw and cage

Interventions

TLIF and unilateral pedicle screw fixation

TLIF combined with posterior unilateral pedicle screw fixation

Intervention Type: PROCEDURE

TLIF and bilateral pedicle screw fixation

TLIF combined with posterior bilateral pedicle screw fixation

Intervention Type: PROCEDURE

Pedicle screw and cage

Pedicle screw and cage

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xiaofei Cheng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

SNPHO-161116

Identifier Type: -

Identifier Source: org_study_id