Clinical Performance

Fusion rates were equivalent to autograft, including the ability to achieve fusion in 100% of one and two level procedures.

Single Level


Two Level


Three Level


Four Level
 

INTEGRA MOZAIK 
OSTEOCONDUCTIVE SCAFFOLD

Clinically Proven — Integra Mozaik Osteoconductive
Scaffold has been shown to be equally effective to autograft

 A key clinical study on the use of the Integra Mozaik matrix (versus autograft) in posterolateral lumbar fusion supports the product’s safety and effectiveness as an alternative to autograft.
 

      
  • Equivalent performance between the Integra Mozaik scaffold and autograft
     
  • Success in a patient population containing many common confounding factors or comorbidities including smoking, diabetes, and osteoporosis
     
  • In cases of successful fusion, definitive, uninterrupted bridging of well mineralized trabecular bone was observed 12 months after surgery, as determined by an independent radiologist blinded to treatment
     
  • Integra Mozaik scaffold applied as indicated with bone marrow aspirate alone, no addition of autograft or allograft
     
  • Spinal fusion comparisons performed in each patient individually, Integra Mozaik scaffold applied to the symptomatic side and autograft to the contralateral side
     
        
Availability

Representative radiographs from the referenced study. CT-scans from two patients at 12 months post-op.