Clinical trial NCT06971835: INDUCE: A Prospective 2-Year Spine Registry
Official title: Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Subjects Treated With NMP as Part of Their Spine Surgery
Degenerative Disc Disease (DDD)
Keywords: degenerative spine
NMP
Induce
Lead sponsor: Red Rock Regeneration Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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

Primary outcomes:
measure: Fusion
timeFrame: 6 month and 12 month post surgery, and 24 month post surgery
measure: Serious Adverse Events and Subsequent Surgical Interventions
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
measure: Change in Pain
timeFrame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
measure: Change in Disability
timeFrame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
measure: Change in Quality of Life
timeFrame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Other outcomes:
Locations:
Study officials:
References: