Spinal Stenosis Clinical Trial
Official title:
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult aged 18 years or older - Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD) - Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons Exclusion Criteria: - Subject had history of previous back operations at the time of the index procedure - Subject had extraspinal cause of back pain or sciatica at the time of the index procedure - Severe scoliosis in the lumbar region - Subject was or is currently involved in active litigation - Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
United States | St. Joseph Heritage Healthcare | Fullerton | California |
United States | Michigan Spine Institute | Waterford | Michigan |
Lead Sponsor | Collaborator |
---|---|
Baxano Surgical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Incidence of reported adverse events, including those requiring medical intervention. | 3 months post-operative | Yes |
Secondary | Health Economic | Operative measures including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge. Comparative hospital data |
Up to 3 months post-operative | No |
Secondary | Clinical Effectiveness | A decrease in back pain compared to baseline at 3 months as measured by Visual Analog Scale A decrease in disability compared to baseline at 3 months as measure by the Oswestry Disability Index | 3 months post-operative | No |
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