A Prospective Study of the InterFuse T(tm), | NCT02678130

Studies
A Prospective Study of the InterFuse T(tm),

NCT02678130

Sponsor

Vertebral Technologies, Inc.

Status

Unknown status

Last Update Posted

Nov 2, 2016Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Low Back Pain

Interventions

InterFuse T
Standard of Care TLIF (Stryker AVS Unilif)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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](streamdown:incomplete-link)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InterFuse Group	Active Comparator	Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device	Device: InterFuse T
Control Group: Standard of care TLIF	Active Comparator	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InterFuse T	Device	Transforaminal Lumbar Interbody fusion (TLIF)	InterFuse Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeff Felt, MD	Contact	612-708-4838		jfelt@vti-spine.com
Ben A. Wasscher, MBA	Contact	763-218-4311		bwasscher@vti-spine.com

Overall Officials

Name	Affiliation	Role
Stephen P Kallhorn, MD	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina	Recruiting	Charleston	South Carolina	29425	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

It is anticipated that data will be presented at scientific meetings and that a manuscript will be produced on the study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D055959	Intervertebral Disc Degeneration
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D013122	Spinal Diseases

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided