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

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

Keywords

ClinConnect Summary

This is a prospective, observational study to see how well Natural Matrix Protein™ (NMP™) Fibers work as a bone graft material used during cervical or lumbar spine fusion for people with degenerative spine conditions. About 200 adults are planned to participate (roughly 100 having lumbar fusion and 100 having cervical fusion). Researchers will review medical records, collect X-ray images, and ask patients about their outcomes over up to 12 months after surgery. The main goals are to find out how often the fused bones are completed successfully, whether patients need any additional spine surgery on the treated levels, and whether any safety issues related to the NMP fibers occur.

Who may be eligible: adults 18 or older with degenerative disc disease, spinal stenosis, or spondylolisthesis who are undergoing cervical or lumbar fusion at up to three adjacent levels and who will be treated with NMP Fibers. Participants will have four study visits over the year after surgery, with follow-up care continuing as part of standard practice. Outcomes will include the fusion rate on X‑rays, any secondary surgeries, safety events related to the product, and changes in pain and disability scores (such as ODI for lower back and NDI for the neck), along with related pain measurements. The study is sponsored by Induce Biologics USA Inc. and being conducted at the Alabama Back Institute in Jasper, Alabama.

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.