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A Prospective Study of the InterFuse T(tm),

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
InterFuse T
Standard of Care TLIF (Stryker AVS Unilif)
Sponsored by
Vertebral Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

InterFuse Group

Control Group: Standard of care TLIF

Arm Description

Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device

treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)

Outcomes

Primary Outcome Measures

fusion rates
Assessment of the fusion rates as demonstrated by radiographic evidence.

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2016
Last Updated
November 1, 2016
Sponsor
Vertebral Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02678130
Brief Title
A Prospective Study of the InterFuse T(tm),
Official Title
A Prospective Study of the InterFuse T(tm)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertebral Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
InterFuse Group
Arm Type
Active Comparator
Arm Description
Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device
Arm Title
Control Group: Standard of care TLIF
Arm Type
Active Comparator
Arm Description
treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)
Intervention Type
Device
Intervention Name(s)
InterFuse T
Intervention Description
Transforaminal Lumbar Interbody fusion (TLIF)
Intervention Type
Device
Intervention Name(s)
Standard of Care TLIF (Stryker AVS Unilif)
Intervention Description
Transforaminal Lumbar Interbody Fusion (TLIF)
Primary Outcome Measure Information:
Title
fusion rates
Description
Assessment of the fusion rates as demonstrated by radiographic evidence.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Visual Analog Scale pre-op compared to VAS score at 2-4 weeks, 6 months and at 1 year
Time Frame
up to 12 months
Title
Oswestry Disability Score (ODI)
Description
Oswestry Low Back Pain Disability Questionaire
Time Frame
12 months
Title
SF-36
Description
Rand 36-item Health Survey (version 1.0)
Time Frame
12 months
Title
Maintenance of disk height
Description
comparison of disk height pre-op versus at 12 months
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Length of hospital stay
Time Frame
up to 2-4 weeks
Title
Opioid use
Description
usage of pain medication
Time Frame
baseline, at 2-4 weeks, at 6 months and at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Felt, MD
Phone
612-708-4838
Email
jfelt@vti-spine.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ben A. Wasscher, MBA
Phone
763-218-4311
Email
bwasscher@vti-spine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Kallhorn, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
CHarleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hudson
Phone
843-792-3790
Email
hudsoncm@musc.edu
First Name & Middle Initial & Last Name & Degree
Michelle DeCandio, RN,OCN,CCRP
Phone
843-792-9016
Email
decandio@musc.edu
First Name & Middle Initial & Last Name & Degree
Stephen P Kallhorn, MD
First Name & Middle Initial & Last Name & Degree
Abhay K Varma, MD
First Name & Middle Initial & Last Name & Degree
Bruce Frankel, MD
First Name & Middle Initial & Last Name & Degree
Alejandro Spiotta, MD
First Name & Middle Initial & Last Name & Degree
Raymond Turner IV, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study

Learn more about this trial

A Prospective Study of the InterFuse T(tm),

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