Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mark A Prevost Sr, MD · PRINCIPAL_INVESTIGATOR · Alabama Back Institute
- Mark A Prevost II, MD · PRINCIPAL_INVESTIGATOR · Alabama Back Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Incidence of interbody fusionBaseline 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 interventionBaseline 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 EventsBaseline 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.