A Prospective Study of the InterFuse T(tm),

Phase 4

• Conditions: Low Back Pain
• Interventions: Device: InterFuse T; Device: Standard of Care TLIF (Stryker AVS Unilif)

• Registration Number: NCT02678130
• Lead Sponsor: Vertebral Technologies, Inc.

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02
• Primary Completion: 2018-06
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InterFuse Group	InterFuse T	Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device
Control Group: Standard of care TLIF	Standard of Care TLIF (Stryker AVS Unilif)	treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)

Primary Outcome Measures

Name	Time	Method
fusion rates	12 months	Assessment of the fusion rates as demonstrated by radiographic evidence.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 CHarleston, South Carolina, United States