INDUCE: A Prospective 2-Year Spine Registry

Red Rock Regeneration Inc.

Status: Not yet enrolling

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

Treatments: Device: NMP

Study type: Observational

Funder types: Industry

Identifiers

NCT06971835

CT-NMP-009

Details and patient eligibility

About

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.

Full 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)

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

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

Description:

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.

Treatment:

Device: NMP