Fibergraft Interbody Fusion Retrospective

Degenerative Disc Disease Clinical Trial

— FIFR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898232
• Other study ID #: FIFR-28
• Status: Completed
• Start date: May 9, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: January 2021
• Source: Bone and Joint Clinic of Baton Rouge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Spinal Degeneration
• Spinal Stenosis
• Spondylolisthesis

Intervention

Radiation:
• Computed Tomography (CT) Scan of the Lumbar Spine
Patients in the cohort who have not received a 12 month post-op CT scan will be asked to enroll in the study and undergo a CT of the lumbar spine.

Locations

Country	Name	City	State
United States	Bone and Joint Clinic of Baton Rouge	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Bone and Joint Clinic of Baton Rouge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion Rate	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).	12 months post-operatively
Secondary	Mean change in Visual Analog (VAS) Pain scale	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.	Pre-operatively to 12 months post-operatively
Secondary	Mean change in Oswestry Disability Index (Function) score	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	Pre-operatively to 12 months post-operatively