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Completed

NCT Number: NCT03898232

Fibergraft Interbody Fusion Retrospective

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Degenerative Spondylolisthesis Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Degeneration Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography (CT) Scan of the Lumbar Spine

Radiation

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.

Primary outcomes

  1. 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

  1. Mean change in Visual Analog (VAS) Pain scale

    Time frame: 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.

  2. Mean change in Oswestry Disability Index (Function) score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bone and Joint Clinic of Baton Rouge

Other

Registry information

Official study 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

Acronym: FIFR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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