Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

Lumbar Foraminal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985138
• Other study ID #: SNPHO-161116
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 2021

Study information

• Verified date: January 2022
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Foraminal Stenosis

Intervention

Procedure:
• TLIF and unilateral pedicle screw fixation
TLIF combined with posterior unilateral pedicle screw fixation
• TLIF and bilateral pedicle screw fixation
TLIF combined with posterior bilateral pedicle screw fixation

Device:
• Pedicle screw and cage
Pedicle screw and cage

Locations

Country	Name	City	State
China	Department of Orthopedic Surgery, Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) scores		2 years postoperatively
Secondary	Adverse events related to procedure		2 years postoperatively
Secondary	Operative duration		1 week postoperatively
Secondary	Estimated blood loss		1 week postoperatively
Secondary	Length of hospital stay		1 week after discharge
Secondary	Spinal angles	Radiographic parameters	2 years postoperatively
Secondary	Intervertebral space height	Radiographic parameters	2 years postoperatively
Secondary	Foraminal height	Radiographic parameters	2 years postoperatively
Secondary	Cost of treatment		2 years postoperatively
Secondary	Fusion rate		2 years postoperatively
Secondary	Oswestry Disability Index (ODI)		2 years postoperatively