NCT03898232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 20, 2019

Last Update Submit

January 27, 2021

Conditions

Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal DegenerationSpinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mean change in Visual Analog (VAS) Pain scale

    Pre-operatively to 12 months post-operatively

  • Mean change in Oswestry Disability Index (Function) score

    Pre-operatively to 12 months post-operatively

Interventions

Computed Tomography (CT) Scan of the Lumbar SpineRADIATION

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent a Lumbar Interbody Fusion (LIF) at 1-3 levels augmented with Prosidyan Fibergraft Putty.

You may qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 1, 2019

Study Start

May 9, 2019

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

US(1)