A Prospective Study of the InterFuse T(tm),

Low Back Pain Clinical Trial

Official title:

A Prospective Study of the InterFuse T(tm)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678130
• Other study ID #: VTI-011
• Status: Recruiting
• Phase: Phase 4
• First received: January 22, 2016
• Last updated: November 1, 2016
• Start date: January 2015
• Est. completion date: January 2019

Study information

• Verified date: November 2016
• Source: Vertebral Technologies, Inc.
• Contact: Jeff Felt, MD
• Phone: 612-708-4838
• Email: jfelt[@]vti-spine.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	CHarleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vertebral Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay		up to 2-4 weeks	No
Other	Opioid use	usage of pain medication	baseline, at 2-4 weeks, at 6 months and at 12 months	No
Primary	fusion rates	Assessment of the fusion rates as demonstrated by radiographic evidence.	12 months	No
Secondary	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	No
Secondary	Oswestry Disability Score (ODI)	Oswestry Low Back Pain Disability Questionaire	12 months	No
Secondary	SF-36	Rand 36-item Health Survey (version 1.0)	12 months	No
Secondary	Maintenance of disk height	comparison of disk height pre-op versus at 12 months	12 months	No