Fibergraft Interbody Fusion Retrospective

Completed

• Conditions: Degenerative Spondylolisthesis; Spinal Degeneration; Degenerative Disc Disease; Spinal Stenosis

• Registration Number: NCT03898232
• Lead Sponsor: Bone and Joint Clinic of Baton Rouge

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: Retrospective chart review with prospective data collection.

Procedures: Patients will be screened by retrospective chart review. Eligible patients will be contacted and asked to participate. Consenting patients will answer questionnaires and undergo a CT lumbar scan.

Study Product / Intervention: The device under investigation is Prosidyan Fibergraft. However, since study subjects are retrospectively enrolled, they will have received the device before entering the study.

Study Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Study Start: 2019-05-09
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion Rate	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 Outcome Measures

Name	Time	Method
Mean change in Oswestry Disability Index (Function) score	Pre-operatively to 12 months post-operatively	Mean change in low back functional status as measured by the Oswestry Disability Index where a score of 0 indicates no disability and a score of 100 represents maximum disability
Mean change in Visual Analog (VAS) Pain scale	Pre-operatively to 12 months post-operatively	Mean change in low back pain as measured by a 100 mm Visual Analog Scale where 0 indicates no pain and 100 indicates the greatest pain.

Trial Locations

Locations (1)

Bone and Joint Clinic of Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States