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Enrolling by Invitation

NCT Number: NCT06971835

INDUCE: A Prospective 2-Year Spine Registry

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.

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Key information

Conditions

Subjects Treated With NMP as Part of Their Spine Surgery Bone Diseases Degenerative Disc Disease (DDD) Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spine Center of Louisiana, Baton Rouge, Louisiana, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Fusion

    Time frame: 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.

  2. Serious Adverse Events and Subsequent Surgical Interventions

    Time frame: Through study completion, an average of 2 years.

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

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop

    Pain scores will be reported as assessed by Visual Analog Scale scores, (0-100mm) or Numeric Rating Scale (0-10) depending on institutions standard of care. Higher score indicates increased pain.

  2. Change in Disability

    Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop

    Disability improvement as measured by Oswestry Disability Index (ODI) or Neck Disability Index (NDI), as applicable, 0-100%. High score indicates increase disability.

  3. Change in Quality of Life

    Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop

    Improvement in qualify of life as measured by Veterans Rand-12, 0-100. High score indicates increase quality of life.

Sponsors and collaborators

Lead sponsor

Red Rock Regeneration Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 14, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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