INDUCE: A Prospective 2-Year Spine Registry

NCT ID: NCT06971835

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2029-01-31

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.

Detailed Description

This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with NMP Fibers and/or Micro Particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study.

PRIMARY ENDPOINTS

• Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s)
• Effectiveness - presence of fusion as measured by x-rays and if available CT.

SECONDARY ENDPOINTS

Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:

• Baseline demographics and medical history
• Duration of hospitalization
• Operative time
• Estimated blood loss
• Neurological status
• Subject patient reported outcomes as applicable including, but not limited to:

• Oswestry Disability Index (ODI)/ Neck Disability Index (NDI)
• Visual Analog Scale (VAS) Pain
• Veteran Rand 12-Item Health Survey (VR-12)

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

NMP

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Red Rock Regeneration Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CT-NMP-009

Identifier Type: -

Identifier Source: org_study_id