Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

• ClinicalTrials.gov Identifier: NCT02985138
• Recruitment Status: Completed
• First Posted: December 7, 2016
• Last Update Posted: January 25, 2022
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Information provided by (Responsible Party): Xiaofei Cheng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Foraminal Stenosis	Procedure: TLIF and unilateral pedicle screw fixation; Procedure: TLIF and bilateral pedicle screw fixation; Device: Pedicle screw and cage	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: September 2021
• Actual Study Completion Date: September 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale (VAS) scores [ Time Frame: 2 years postoperatively ]

Secondary Outcome Measures :

1. Adverse events related to procedure [ Time Frame: 2 years postoperatively ]
2. Operative duration [ Time Frame: 1 week postoperatively ]
3. Estimated blood loss [ Time Frame: 1 week postoperatively ]
4. Length of hospital stay [ Time Frame: 1 week after discharge ]
5. Spinal angles [ Time Frame: 2 years postoperatively ]
   Radiographic parameters
6. Intervertebral space height [ Time Frame: 2 years postoperatively ]
   Radiographic parameters
7. Foraminal height [ Time Frame: 2 years postoperatively ]
   Radiographic parameters
8. Cost of treatment [ Time Frame: 2 years postoperatively ]
9. Fusion rate [ Time Frame: 2 years postoperatively ]
10. Oswestry Disability Index (ODI) [ Time Frame: 2 years postoperatively ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

China

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, China, 200011

Sponsors and Collaborators

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

More Information

• Responsible Party: Xiaofei Cheng, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• ClinicalTrials.gov Identifier: NCT02985138
• Other Study ID Numbers: SNPHO-161116
• First Posted: December 7, 2016
• Last Update Posted: January 25, 2022
• Last Verified: January 2022

Additional relevant MeSH terms:

Constriction, Pathologic; Pathological Conditions, Anatomical