Status:
ENROLLING_BY_INVITATION
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Lead Sponsor:
Induce Biologics USA Inc.
Conditions:
Degenerative Disc Disease
Degenerative Spondylolisthesis
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (...
Detailed Description
The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires. The study population will include 100 consecutive lumb...
Eligibility Criteria
Inclusion
- Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
- Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
- Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
- Subject must be 18 years of age or older at the time of consent;
- Subject must be willing and able to sign an informed consent document;
- Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.
Exclusion
- Subject is under 18 years of age at the time of consent;
- Subject is 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;
- Subject is currently imprisoned.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06000319
Start Date
January 4 2024
End Date
August 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Alabama Back Institute
Jasper, Alabama, United States, 35501