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

NCT02171169 | Unknown

• 1 other identifier: PR-07875
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Spinal Stenosis; Spondylolisthesis; Degenerative Disc Disease (DDD)

Outcome Measures

Primary Outcomes (1)

• Safety

  Incidence of reported adverse events, including those requiring medical intervention.

  3 months post-operative

Secondary Outcomes (2)

• Health Economic

  Up to 3 months post-operative

• Clinical Effectiveness

  3 months post-operative

Study Arms (2)

Transsacral lumbar interbody fusion

Transforaminal lumbar interbody fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject candidates are those that have been treated with either the transsacral or transforaminal lumbar interbody fusion procedure at least one year prior to this evaluation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxano Surgical, Inc.: lead

Study Sites (3)

St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Michigan Spine Institute

Waterford, Michigan, 48328, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Peter Whang, MD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

US (3)