Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures

Spinal Stenosis Clinical Trial

Official title:

Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02171169
• Other study ID #: PR-07875
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 19, 2014
• Last updated: September 2, 2014
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2014
• Source: Baxano Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Western Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

Study Objective:

The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).

Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.

Study Design, Endpoints:

Primary Endpoint:

Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.

Secondary Endpoints:

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, as applicable.

Health Economic: Comparative hospital data (from time of admission through time of discharge)

Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).

Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).

Study Design, Enrollment:

Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.

Study Design, Analyses:

The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Degenerative Disc Disease (DDD)
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spondylolisthesis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baxano Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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