Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in MI-TLIF

Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in Minimally Invasive Transforaminal Lumbar Interbody Fusions

The purpose of this study is to compare the healing of the patients spine at 24-months following surgery and screw placement among 3 groups. The doctor will also compare clinical outcomes and the immediate and delayed medical and surgical complications among the 3 study groups. The goal of this study is to determine if treating patients with one of the 3 groups is better than the others.

Study Overview

• Status: Terminated
• Conditions: Lumbar Disease
• Intervention / Treatment: Device: Pedicle Screw

Detailed Description

Patient must be between 18 and 80 years old and have problems with the bones in there lower back (lumbar disease) for which Cautious management over at least 3 months has not brought relief from back and/or leg pain. Patients will be scheduled to undergo surgery to treat there lumbar disease. The surgery will be followed by placement of screws in the back of the bones of there lower back. This includes placing solid metal rods that are connected and secured to adjacent vertebrae (bones of the back) using screws. The screws are used to hold the spine together. Everyone who takes part in this study will be assigned to one of the following 3 study groups: 1) One-sided screw placement into the bones above and below the area where the nerve is being surgically relieved of its pinching; 2) Same as group 1 but with an additional stand alone screw which crosses the spinal joint placed into the joint on the other side; 3) Screw placement on both sides into the bones above and below the area where the nerve is being surgically relieved of its pinching.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Unviersity

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18-80 years.
• Symptomatic single-level lumbar disease including lumbosacral junction.
• Unilateral leg-dominant pain non-responsive to conservative management with concordant imaging findings. These include degenerative spondylolisthesis (grade 1 or 2), facet arthropathy +/- lateral disc herniation, recurrent disc herniation, or large central disc herniation.
• Back pain of confirmed discogenic origin (single level disease only).
• Failed conservative management for a minimum of 3 months.
• Negative serum pregnancy test (for women of childbearing potential)

Exclusion Criteria:

• Severe bilateral leg symptoms.
• Prior instrumented arthrodesis at any lumbar level.
• History of osteoporosis.
• Co-morbidities requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, immunosuppressive agent, methotrexate).
• Severe co-morbidities (e.g., heart, respiratory, or renal disease).
• Recent (<3 yrs) Co-incident spinal tumor or infection.
• Greater than single level symptomatic involvement.
• Associated thoracolumbar kyphotic or scoliotic deformity (>10).
• Morbid obesity (BMI > 40).
• History of metal sensitivity/foreign body sensitivity.
• Concurrent involvement in another investigational drug or device study that could confound study data.
• History of substance abuse (recreational drugs, prescription drugs, or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
• Subjects who are pregnant or plan to become pregnant in the next 24 months.
• Prisoner.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Unilateral pedicle screws	Device: Pedicle Screw
Other: Group 2; Ipsilateral pedicle screws, contralateral facet screw	Device: Pedicle Screw
Other: Group 3; Bilateral pedicle screws	Device: Pedicle Screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Bony Fusion Rates Radiographically Using CT Scans	Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey	To compare clinical outcomes among the three study arms utilizing the Visual Analog Scale (VAS) survey. Visual analog scales will be used to assess neck, back, arm, and leg pain. Scores can range from 0 - 10 with higher scores indicating higher levels of pain.	3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey	To compare clinical outcomes among the three study arms utilizing the Oswestry Disability Idex (ODI) survey. This survey will be used to assess how back pain affects patients' ability to function in everyday life. Scores can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life.	3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2)	To compare clinical outcomes among the three study arms utilizing the Short Form 36 Health Survey (SF-36). This survey will be used to assess patients' physical and mental health. Scores range from 0 to 100 with higher scores indicating better physical and mental health.	3 months, 6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome: Immediate and Delayed Medical and Surgical Complications Compared Among the Three Arms	Immediate and delayed medical and surgical (including neurological) complications among the three study arms will be compared.	post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months
Exploratory Outcome: Compare Bony Fusion Rates Using X-ray Based Classification Scale	Comparison of bony fusion rates at 12 and 24 months among the three study arms, using an X-ray based classification scale.	12 months and 24 months

Collaborators and Investigators

• Sponsor: H Francis Farhadi, MD, PhD
• Investigators: Principal Investigator: H. Francis Farhadi, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2013H0171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No