Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Launched by INDUCE BIOLOGICS USA INC. · Aug 16, 2023

Keywords

ClinConnect Summary

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 lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria.

There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
• • 2. 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;
• • 3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
• • 4. Subject must be 18 years of age or older at the time of consent;
• • 5. Subject must be willing and able to sign an informed consent document;
• • 6. 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 Criteria:
• • 1. Subject is under 18 years of age at the time of consent;
• • 2. 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;
• • 3. Subject is currently imprisoned.