A Prospective Study of the InterFuse T(tm),

Vertebral Technologies

Status and phase: Unknown; Phase 4

Conditions: Low Back Pain

Treatments: Device: InterFuse T; Device: Standard of Care TLIF (Stryker AVS Unilif)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02678130

VTI-011

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

InterFuse Group

Active Comparator group

Description:

Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device

Treatment:

Device: InterFuse T

Control Group: Standard of care TLIF

Active Comparator group

Description:

treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)

Treatment:

Device: Standard of Care TLIF (Stryker AVS Unilif)