A Prospective Study of the InterFuse T(tm),

Overview

The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.

Full Title of Study: “A Prospective Study of the InterFuse T(tm)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2018

Detailed Description

The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T ™ device in [patients undergoing interbody fusion. The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study

Interventions

  • Device: InterFuse T
    • Transforaminal Lumbar Interbody fusion (TLIF)
  • Device: Standard of Care TLIF (Stryker AVS Unilif)
    • Transforaminal Lumbar Interbody Fusion (TLIF)

Arms, Groups and Cohorts

  • Active Comparator: InterFuse Group
    • Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device
  • Active Comparator: Control Group: Standard of care TLIF
    • treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker’s AVS Unilif)

Clinical Trial Outcome Measures

Primary Measures

  • fusion rates
    • Time Frame: 12 months
    • Assessment of the fusion rates as demonstrated by radiographic evidence.

Secondary Measures

  • Visual Analog Scale (VAS)
    • Time Frame: up to 12 months
    • Visual Analog Scale pre-op compared to VAS score at 2-4 weeks, 6 months and at 1 year
  • Oswestry Disability Score (ODI)
    • Time Frame: 12 months
    • Oswestry Low Back Pain Disability Questionaire
  • SF-36
    • Time Frame: 12 months
    • Rand 36-item Health Survey (version 1.0)
  • Maintenance of disk height
    • Time Frame: 12 months
    • comparison of disk height pre-op versus at 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • meets indications for an interbody fusion (determined by the study investigator) – Has documented conservative (non-operative ) treatment for at least 3 months – Has a VAS back pain of > or = 60mm – Has an ODI > or = 40% – at least 18 years of age and skeletally mature – Willing and able to comply with study requirements – Patient's condition is appropriate for surgery – Agreed to participate in study Exclusion Criteria:

  • Has severe osteoporosis or osteopenia – Grade 3 or higher Spondylolisthesis – Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation – Body Mass Index (BMI) > 40 – Patient has active infection – Patient is pregnant or planning to become pregnant – Patient is mentally ill or has history of drug abuse – Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum – Patient is currently enrolled in an investigational spine study – Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease – patient bhas symptomatic fibrous arachnoiditis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vertebral Technologies, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen P Kallhorn, MD, Principal Investigator, Medical University of South Carolina
  • Overall Contact(s)
    • Jeff Felt, MD, 612-708-4838, jfelt@vti-spine.com

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