Degenerative Disc Disease Clinical Trial
— FIFROfficial 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
NCT number | NCT03898232 |
Other study ID # | FIFR-28 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 9, 2019 |
Est. completion date | February 20, 2020 |
Verified date | January 2021 |
Source | Bone and Joint Clinic of Baton Rouge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | February 20, 2020 |
Est. primary completion date | February 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Bone and Joint Clinic of Baton Rouge | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Bone and Joint Clinic of Baton Rouge |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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