Clinical trial NCT02678130: A Prospective Study of the InterFuse T(tm),
Official title: A Prospective Study of the InterFuse T(tm)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Intervertebral disc degeneration
Bone Disease
Musculoskeletal disease
Spinal disease
Lead sponsor: Vertebral Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: fusion rates
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: up to 12 months
measure: Oswestry Disability Score (ODI)
timeFrame: 12 months
measure: SF-36
timeFrame: 12 months
measure: Maintenance of disk height
timeFrame: 12 months
Other outcomes:
measure: Length of hospital stay
timeFrame: up to 2-4 weeks
measure: Opioid use
timeFrame: baseline, at 2-4 weeks, at 6 months and at 12 months
Locations:
city: CHarleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Stephen P Kallhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: