A Prospective Study of the InterFuse T(tm),
Status: | Recruiting |
---|---|
Conditions: | Back Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 89 |
Updated: | 4/21/2016 |
Start Date: | January 2015 |
End Date: | January 2019 |
Contact: | Jeff Felt, MD |
Email: | jfelt@vti-spine.com |
Phone: | 612-708-4838 |
A Prospective Study of the InterFuse T(tm)
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.
lumbar interbody device is at least equal in safety and efficacy to other (standard of care)
TLIF devices.
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
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
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Stephen P Kallhorn, MD
Phone: 843-792-3790
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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