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.
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)
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Fusion
Incidence of fusion at treated levels as measured by x-rays and if available CT, will be reported.
Time frame: 6 month and 12 month post surgery, and 24 month post surgery
Serious Adverse Events and Subsequent Surgical Interventions
Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported.
Time frame: Through study completion, an average of 2 years.
Change in Pain
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.
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Disability
Disability improvement as measured by Oswestry Disability Index (ODI) or Neck Disability Index (NDI), as applicable, 0-100%. High score indicates increase disability.
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Quality of Life
Improvement in qualify of life as measured by Veterans Rand-12, 0-100. High score indicates increase quality of life.
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
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