Fibergraft Interbody Fusion Retrospective (FIFR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03898232|
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
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|
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.
PRIMARY: To assess the fusion rate in this retrospective cohort at 12 months post-operatively.
- 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|
|Estimated Enrollment :||120 participants|
|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|
- 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.
- 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).
- 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.
- 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