Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2015-01-31
2019-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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InterFuse Group
Patients are randomized based on last digit (odd) of social security number to be treated with an InterFuse T device
InterFuse T
Transforaminal Lumbar Interbody fusion (TLIF)
Control Group: Standard of care TLIF
treated with a standard of care TLIF (Transforaminal Lumbar Interbody Fusion) device (e.g. Stryker's AVS Unilif)
Standard of Care TLIF (Stryker AVS Unilif)
Transforaminal Lumbar Interbody Fusion (TLIF)
Interventions
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InterFuse T
Transforaminal Lumbar Interbody fusion (TLIF)
Standard of Care TLIF (Stryker AVS Unilif)
Transforaminal Lumbar Interbody Fusion (TLIF)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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Vertebral Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen P Kallhorn, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Christine Hudson
Role: primary
Michelle DeCandio, RN,OCN,CCRP
Role: backup
Other Identifiers
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VTI-011
Identifier Type: -
Identifier Source: org_study_id