Natural Matrix Protein (NMP) FibersLumbar interbody fusionCervical interbody fusion
Natural Matrix Protein (NMP) Fibers: human bone allograft
Lumbar interbody fusion: Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between L1 and S1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
Cervical interbody fusion: Procedure that involves removing the intervertebral disk from the disk space between between 2 or more vertebrae between C2 and T1. When the disk space has been cleared out, the surgeon fills the void between the vertebrae with a bone void filler.
Study summary
The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
4. Subject must be 18 years of age or older at the time of consent;
5. Subject must be willing and able to sign an informed consent document;
6. Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.
Exclusion Criteria:
1. Subject is under 18 years of age at the time of consent;
2. Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
3. Subject is currently imprisoned.
Primary outcome measure(s)
Incidence of interbody fusion — Baseline to 12 months post-operative Flexion and Extensions radiographs will be assessed for fusion at each level to be fused Fusion is defined as: (1) less than 5 degrees of motion by flexion extension X-ray and (2) no radiological features of non-union (radiolucency, implant migration, loss of graft height, supplemental fixation failure). Both fusion criteria have to be met to be considered a fusion success at the index level.
Incidence of secondary surgical intervention — Baseline to 12 months post-operative Secondary surgical interventions (SSI) include revision, re-operation, removal, or supplemental fixation at the index levels
Incidence of Adverse Product Related Events — Baseline to 12 months post-operative the incidence of the following will be reported: bone resorption with cage migration or subsidence, local inflammation with seromas, ectopic bone formation, radiculitis.
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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