NCT03898232

Fibergraft Interbody Fusion Retrospective

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Bone and Joint Clinic of Baton Rouge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-09
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2019-04-01
• Last updated: 2021-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study