Recruiting

InterFuse T

Sponsor:

Vertebral Technologies, Inc.

Code:

NCT02678130

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

InterFuse T

Standard of Care TLIF (Stryker AVS Unilif)

Study Details

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.

Conditions

Low Back Pain

Study ID

NCT02678130

Start date

Jan, 2015

Status verified date

Nov, 2016

Completion date

Jan, 2019

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

InterFuse T

Transforaminal Lumbar Interbody fusion (TLIF)

Standard of Care TLIF (Stryker AVS Unilif)

Transforaminal Lumbar Interbody Fusion (TLIF)

Primary outcome measure

  • fusion rates [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jeff Felt, MD

612-708-4838jfelt@vti-spine.com

Ben A. Wasscher, MBA

763-218-4311bwasscher@vti-spine.com

Locations

Medical University of South Carolina

Recruiting

CHarleston, South Carolina, United States, 29425

Contacts

Christine Hudson

843-792-3790hudsoncm@musc.edu

Michelle DeCandio, RN,OCN,CCRP

843-792-9016decandio@musc.edu

Principal Investigator:

Stephen P Kallhorn, MD

More Information

Sponsor

Vertebral Technologies, Inc.

Last update posted

Nov 2, 2016

Last verified

Nov, 2016

Keywords

  • Intervertebral disc degeneration
  • Bone Disease
  • Musculoskeletal disease
  • Spinal disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vertebral Technologies, Inc. on 2016-11-02.