A Prospective Study of the InterFuse T(tm),

A Prospective Study of the InterFuse T(tm)

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Device: InterFuse T; Device: Standard of Care TLIF (Stryker AVS Unilif)

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • CHarleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Christine Hudson; Phone Number: 843-792-3790; Email: hudsoncm@musc.edu
      • Contact: Michelle DeCandio, RN,OCN,CCRP; Phone Number: 843-792-9016; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fusion rates	Assessment of the fusion rates as demonstrated by radiographic evidence.	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		up to 2-4 weeks
Opioid use	usage of pain medication	baseline, at 2-4 weeks, at 6 months and at 12 months

Collaborators and Investigators

• Sponsor: Vertebral Technologies, Inc.
• Investigators: Principal Investigator: Stephen P Kallhorn, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Musculoskeletal disease; Intervertebral disc degeneration; Bone Disease; Spinal disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: VTI-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study