NCT06971835

INDUCE: A Prospective 2-Year Spine Registry

Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Red Rock Regeneration Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-12-01
• Completion: 2029-01-01
• First posted: 2025-05-14
• Last updated: 2025-07-22