A Prospective Study of the InterFuse T(tm),

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective Study of the InterFuse T(tm)

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: InterFuse T
* Device: Standard of Care TLIF (Stryker AVS Unilif)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: InterFuse Group<br>Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device | Device: InterFuse T<br>* Transforaminal Lumbar Interbody fusion (TLIF)<br>|
| Active Comparator: Control Group: Standard of care TLIF<br>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)<br>* Transforaminal Lumbar Interbody Fusion (TLIF)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 12 months | 
| SF-36 | Rand 36-item Health Survey (version 1.0) | 12 months | 
| Maintenance of disk height | comparison of disk height pre-op versus at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervertebral disc degeneration, Bone Disease, Musculoskeletal disease, Spinal disease