Degenerative Disc Disease (DDD), Subjects Treated With NMP as Part of Their Spine Surgery
Conditions
Keywords
degenerative spine, NMP, Induce
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)
Interventions
DEVICENMP
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.
Sponsors
Red Rock Regeneration Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 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. |
| Serious Adverse Events and Subsequent Surgical Interventions | Through study completion, an average of 2 years. | Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | 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. |
| Change in Disability | 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. |
| Change in Quality of Life | 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. |
Countries
United States
Outcome results
None listed