INDUCE: A Prospective 2-Year Spine Registry

Launched by RED ROCK REGENERATION INC. · May 7, 2025

Keywords

ClinConnect Summary

The INDUCE clinical trial is studying the use of a treatment called Natural Matrix Protein® (NMP®) to help with spinal fusion, which is a procedure often needed for people with degenerative disc disease (DDD). This trial will look at how safe and effective NMP is when used during spine surgery, specifically in the cervical (neck) and lumbar (lower back) regions. Researchers will also gather feedback from patients about their recovery and experiences after the surgery.

To be eligible for this trial, participants need to be at least 18 years old and must have NMP implanted in their spine during surgery. It's important that NMP makes up at least half of the total bone graft material used in the surgery. Participants will need to sign a consent form before the surgery and complete some questionnaires about their health. The trial is not currently recruiting participants, but it will involve regular follow-ups to monitor recovery and outcomes over two years. If you or a loved one are considering spine surgery and meet the criteria, this trial could be an opportunity to contribute to important research in spinal health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Implanted on-label with NMP in at least one vertebral level in the cervical (C1-C7) or lumbar (L1-S1) spine as part of their surgery
• • 2. Total volume of bone graft or bone graft substitute used in index surgery must contain at least 50% NMP by volume per treated level, where NMP is mixed with other graft material.
• • 3. Skeletally mature (age≥18 years of age)
• • 4. Be willing to sign the study-specific informed consent document prior to index surgery
• Exclusion Criteria:
• • 1. Not willing to sign the study-specific informed consent document prior to index surgery
• • 2. Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS) or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed)
• • 3. Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
• • 4. Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
• • 5. Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
• • 6. Did not complete baseline patient reported outcomes prior to index surgery
• • 7. Incarcerated at the time of surgery or preoperative evaluation