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

NCT01996371 | Terminated Results

• 1 other identifier: 2013H0171
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey

  3 months, 6 months, 12 months, 24 months

• Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey

  3 months, 6 months, 12 months, 24 months

• Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2)

  3 months, 6 months, 12 months, 24 months

Other Outcomes (2)

• Safety Outcome: Immediate and Delayed Medical and Surgical Complications Compared Among the Three Arms

  post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Exploratory Outcome: Compare Bony Fusion Rates Using X-ray Based Classification Scale

  12 months and 24 months

Study Arms (3)

Group 1

OTHER

Unilateral pedicle screws

Device: Pedicle Screw

Group 2

OTHER

Ipsilateral pedicle screws, contralateral facet screw

Device: Pedicle Screw

Group 3

OTHER

Bilateral pedicle screws

Device: Pedicle Screw

Interventions

Pedicle Screw DEVICE

Group 1; Group 2; Group 3

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• H Francis Farhadi, MD, PhD: lead

Study Sites (1)

The Ohio State Unviersity

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This study is being ended early due to low enrollment. No analysis is planned due to the small cohort.

Results Point of Contact

• Title: Shelby Miracle
• Organization: OhioU

shelby.miracle@osumc.edu

614-366-1648

Study Officials

• H. Francis Farhadi, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-10

Locations

US (1)