A Prospective Study of the InterFuse T(tm),

Status unconfirmed · Phase 4

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT02678130

Run by

Vertebral Technologies, Inc.

People needed

60

Starts

2015-01-01

Expected to finish

2019-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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