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Fibergraft Interbody Fusion Retrospective (FIFR)

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ClinicalTrials.gov Identifier: NCT03898232
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Degeneration Spinal Stenosis 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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent a Lumbar Interbody Fusion (LIF) at 1-3 levels augmented with Prosidyan Fibergraft Putty.
Criteria

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

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Responsible Party: Bone and Joint Clinic of Baton Rouge
ClinicalTrials.gov Identifier: NCT03898232     History of Changes
Other Study ID Numbers: FIFR-28
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis