INDUCE: A Prospective 2-Year Spine Registry

NCT06971835 | Enrolling By Invitation

• 1 other identifier: CT-NMP-009
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Degenerative Disc Disease (DDD); Subjects Treated With NMP as Part of Their Spine Surgery

Keywords

degenerative spine; NMP; Induce

Outcome Measures

Primary Outcomes (2)

• Fusion

  Incidence of fusion at treated levels as measured by x-rays and if available CT, will be reported.

  6 month and 12 month post surgery, and 24 month post surgery

• Serious Adverse Events and Subsequent Surgical Interventions

  Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported.

  Through study completion, an average of 2 years.

Secondary Outcomes (3)

• Change in Pain

  Baseline, 3 month, 6 months, 12 months, and 24 months postop

• Change in Disability

  Baseline, 3 month, 6 months, 12 months, and 24 months postop

• Change in Quality of Life

  Baseline, 3 month, 6 months, 12 months, and 24 months postop

Study Arms (1)

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.

Device: NMP

Interventions

NMP DEVICE

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.

Subjects treated on-label with NMP as part of their spine surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study will include a maximum of 10 US sites, covering a large geographic region, representing a diverse demographic cohort.

You may qualify if:

• 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
• 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.
• Skeletally mature (age≥18 years of age)
• Be willing to sign the study-specific informed consent document prior to index surgery

You may not qualify if:

• Not willing to sign the study-specific informed consent document prior to index surgery
• 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)
• Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
• Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
• Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
• Did not complete baseline patient reported outcomes prior to index surgery
• Incarcerated at the time of surgery or preoperative evaluation

Sponsors & Collaborators

• Red Rock Regeneration Inc.: lead

Study Sites (2)

Spine Center of Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 14, 2025
• Study Start: February 17, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)