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Clinical Trials in the USA / NCT06971835
Enrolling by invitation Observational

INDUCE: A Prospective 2-Year Spine Registry

NCT06971835 · tracked via the Priya Life Science USA tracker
Sponsor
Red Rock Regeneration Inc
Phase
Observational
Started
2026-02-17
Last updated
2026-10-19

Condition(s) studied

Subjects Treated With NMP as Part of Their Spine SurgeryDegenerative Disc Disease (DDD)

Investigational drug(s) / intervention(s)

NMP

NMP: The 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 summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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), Demineralized Bone Matrix (DBM), 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

Primary outcome measure(s)

  • Fusion — 6 month and 12 month post surgery, and 24 month post surgery
    Incidence of fusion at treated levels as measured by x-rays and if available CT, will be reported.
  • Serious Adverse Events and Subsequent Surgical Interventions — Through study completion, an average of 2 years.
    Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported.

Trial sites (3)

FacilityCityRegionStatus
Spine Center of Louisiana Baton Rouge Louisiana
Spine Institute of Louisiana Shreveport Louisiana
Huntsman Spinal Clinic Salt Lake City Utah

More Red Rock Regeneration Inc. trials in the USA

Assessing Safety of Cervical Spine Fusion With NMP® Starting soon

Other trials for the same condition

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06971835 on ClinicalTrials.gov ↗ ← All trials in the USA