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A Prospective Study of the InterFuse T(tm),

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678130
Recruitment Status : Unknown
Verified November 2016 by Vertebral Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Vertebral Technologies, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: InterFuse T Device: Standard of Care TLIF (Stryker AVS Unilif) Phase 4

Detailed Description:

The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of the InterFuse T(tm)
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Active Comparator: InterFuse Group
Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device
Device: InterFuse T
Transforaminal Lumbar Interbody fusion (TLIF)

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)
Device: Standard of Care TLIF (Stryker AVS Unilif)
Transforaminal Lumbar Interbody Fusion (TLIF)




Primary Outcome Measures :
  1. fusion rates [ Time Frame: 12 months ]
    Assessment of the fusion rates as demonstrated by radiographic evidence.


Secondary Outcome Measures :
  1. 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

  2. Oswestry Disability Score (ODI) [ Time Frame: 12 months ]
    Oswestry Low Back Pain Disability Questionaire

  3. SF-36 [ Time Frame: 12 months ]
    Rand 36-item Health Survey (version 1.0)

  4. Maintenance of disk height [ Time Frame: 12 months ]
    comparison of disk height pre-op versus at 12 months


Other Outcome Measures:
  1. Length of hospital stay [ Time Frame: up to 2-4 weeks ]
  2. Opioid use [ Time Frame: baseline, at 2-4 weeks, at 6 months and at 12 months ]
    usage of pain medication



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678130


Contacts
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Contact: Jeff Felt, MD 612-708-4838 jfelt@vti-spine.com
Contact: Ben A. Wasscher, MBA 763-218-4311 bwasscher@vti-spine.com

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
CHarleston, South Carolina, United States, 29425
Contact: Christine Hudson    843-792-3790    hudsoncm@musc.edu   
Contact: Michelle DeCandio, RN,OCN,CCRP    843-792-9016    decandio@musc.edu   
Principal Investigator: Stephen P Kallhorn, MD         
Sub-Investigator: Abhay K Varma, MD         
Sub-Investigator: Bruce Frankel, MD         
Sub-Investigator: Alejandro Spiotta, MD         
Sub-Investigator: Raymond Turner IV, MD         
Sponsors and Collaborators
Vertebral Technologies, Inc.
Investigators
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Principal Investigator: Stephen P Kallhorn, MD Medical University of South Carolina

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Responsible Party: Vertebral Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02678130     History of Changes
Other Study ID Numbers: VTI-011
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study
Keywords provided by Vertebral Technologies, Inc.:
Intervertebral disc degeneration
Bone Disease
Musculoskeletal disease
Spinal disease
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms