Red Rock Regeneration Inc.
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 en…
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 allog…
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.
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