Status:
COMPLETED
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
Lead Sponsor:
Induce Biologics USA Inc.
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
Detailed Description
The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires. The study population will include u...
Eligibility Criteria
Inclusion
- Have clinical or radiological evidence of degenerative disc disease of the lumbar spine.
- Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure.
- Be at least 18 years of age.
- Have current contact information.
- Be willing and able to provide written Informed Consent for the prospective part of study participation.
- Be willing and able to undergo a CT-scan and X-rays.
- Be willing and able to complete patient centered outcome questionnaires.
Exclusion
- Currently imprisoned.
- Currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin.
- X-rays or CT-scan are contraindicated.
- Any previous lumbar fusion or arthroplasty surgery at the index level(s)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05972616
Start Date
August 1 2023
End Date
February 21 2024
Last Update
October 14 2025
Active Locations (1)
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1
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101