Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

NCT02985138 | Completed

• 1 other identifier: SNPHO-161116
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) scores

  2 years postoperatively

Secondary Outcomes (10)

• 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

  2 years postoperatively

Study Arms (2)

Unilateral fixation

EXPERIMENTAL

Patients undergoing TLIF and unilateral pedicle screw fixation

Procedure: TLIF and unilateral pedicle screw fixation; Device: Pedicle screw and cage

Bilateral fixation

ACTIVE COMPARATOR

Patients undergoing TLIF and bilateral pedicle screw fixation

Procedure: TLIF and bilateral pedicle screw fixation; Device: Pedicle screw and cage

Interventions

TLIF and unilateral pedicle screw fixation PROCEDURE

TLIF combined with posterior unilateral pedicle screw fixation

Unilateral fixation

TLIF and bilateral pedicle screw fixation PROCEDURE

TLIF combined with posterior bilateral pedicle screw fixation

Bilateral fixation

Pedicle screw and cage DEVICE

Pedicle screw and cage

Bilateral fixation; Unilateral fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, 200011, China

Location

MeSH Terms

Interventions

Pedicle Screws

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CN (1)