INDUCE: A Prospective 2-Year Spine Registry
Part of paid clinical trials in Baton Rouge, Louisiana.
- Sponsor
- Red Rock Regeneration Inc.
- Study ID
- NCT06971835
- Status
- Enrolling By Invitation
Conditions
- Degenerative Disc Disease (DDD)
- Subjects Treated With NMP as Part of Their Spine Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NMP — DEVICEThe study product is Induce Biologics NMP Fibers and NMP Micro Particulates however, this is observational research that involves standard of care. NMP is regulated as a human cellular or tissue-based product (HCT/P) under section 361 of the Public Health Service (PHS) Act and in 21 CFR Part 1271. Under this regulation it did not require clinical evaluation before it could be used commercially. It is indicated for use "as a bone void filler for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the boney structure.
Study Details
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine. The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.
Key Dates
- Start date
- Feb 17, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2028
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Subjects treated on-label with NMP as part of their spine surgery.Subjects 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.
Primary Outcome Measure
Fusion [ Time Frame: 6 month and 12 month post surgery, and 24 month post surgery ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Spine Center of Louisiana | Baton Rouge | Louisiana | 70809 | - |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | - |
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