Subjects Treated With NMP as Part of Their Spine SurgeryDegenerative Disc Disease (DDD)
Investigational drug(s) / intervention(s)
NMP
NMP: 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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