Fibergraft Interbody Fusion Retrospective (FIFR)

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Degenerative Spondylolisthesis; Spinal Degeneration
• Intervention / Treatment: Radiation: Computed Tomography (CT) Scan of the Lumbar Spine

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Bone and Joint Clinic of Baton Rouge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a Lumbar Interbody Fusion (LIF) at 1-3 levels augmented with Prosidyan Fibergraft Putty.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bone and Joint Clinic of Baton Rouge

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: FIFR-28

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes