A Single Surgeon Retrospective Cohort Study of Clinical and Radiological Outcomes Among Patients Treated With Lumbar Interbody Fusion Augmented With Prosidyan Fibergraft® Putty for Degenerative Spinal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Fusion Rate
Study Overview
Brief Summary
A single center study of clinical and radiological outcomes in a retrospective cohort of patients treated with Lumbar Interbody Fusion augmented with Prosidyan Fibergraft for 1 or 2 level degenerative spinal disease by a single surgeon.
Study Design: Retrospective chart review with prospective data collection.
Detailed Description
Background and Rationale: Degenerative pathologies of the lumbar spine including degenerative disc disease, spondylosis and spondylolisthesis are the leading indications for lumbar interbody fusion (LIF) among low back pain patients. Prosidyan's Fibergraft is a bioactive synthetic bone graft substitute that is ultraporous and made from bioactive glass fibers. The proposed study will be an analysis of clinical outcomes among patients who underwent lumbar interbody fusion augmented with Prosidyan Fibergraft by a single surgeon.
Objective(s):
PRIMARY: To assess the fusion rate in this retrospective cohort at 12 months post-operatively.
SECONDARY:
- To report and analyze trends (if any) among diagnosis, number of levels, approach (TLIF, LIF or ALIF) and fusion status.
- To assess pain and functional health changes pre to post-operatively. SAFTEY: To report the rate of surgical adverse events and subsequent surgeries at the operative level.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Previous Lumbar Interbody Fusion (LIF) at 1-3 levels augmented with Prosidyan Fibergraft Putty.
- •No revision or device removal at the operative level(s).
- •Patient did not undergo a Lumbar CT at least 8 months post-operatively.
- •Willing and able to sign Informed Consent.
- •Willing and able to complete questionnaires and undergo CT scan of the Lumbar Spine
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Fusion Rate
Time Frame: 12 months post-operatively
The primary outcome for this study will be the overall fusion rate in the retrospective cohort. Fusion will be assessed from a Lumbar CT scan. The criteria used to assess fusion status will be according to the scale developed by Brantigan, Steffee, and Fraser (BSF criteria).
Secondary Outcomes
- Mean change in Visual Analog (VAS) Pain scale(Pre-operatively to 12 months post-operatively)
- Mean change in Oswestry Disability Index (Function) score(Pre-operatively to 12 months post-operatively)