Fracture Fixation Plates

Fracture Fixation Plates Made with PEEK-OPTIMA™ Ultra-Reinforced, a carbon fiber (CF) composite

PEEK-OPTIMA Ultra-Reinforced combines the high-performance material properties of PEEK-OPTIMATM Natural polymer with the strength imparted by continuous carbon fibers. When manufactured into trauma devices, PEEK-OPTIMA Ultra-Reinforced enables semi-rigid fixation with the potential for improved fatigue and imaging properties over metal. Unlike metals, carbon fiber PEEK (CFR-PEEK) offers the ability to tailor the mechanical properties of the implant without altering the geometry, offering increased design flexibility to meet the device requirements.

Fracture fixation plates composed of PEEK-OPTIMA Ultra-Reinforced have been FDA cleared since 2012, with clinical history dating to at least 20121. Selected published and presented studies demonstrate:

  • Better union rate compared to metallic plates² 
    • 100% union rate for distal femur fractures fixed with CFR-PEEK versus 76% union rate for stainless steel plates. Fewer revisions versus metallic plates
    • 0% hardware failure for distal femur fractures fixed with CFR-PEEK versus 8% hardware failure for stainless steel plates
  • Better reduction compared to metallic plate
    • Restoration of joint line in 98% for distal fibula fractures fixed with CFR-PEEK versus 95% for stainless steel plates3
    • 100% of reductions judged as anatomic or near-anatomic in proximal humerus fractures due to “excellent intra-operative reduction visualization” in fractures without significant deforming forces precluding reduction4
  • Quicker procedures compared to metallic plates
    • 18% reduction in operative time for tri-mallelolar distal fibula fractures versus stainless steel plates5    
  • Comparable functional outcome scores to metal plates in distal fibula fractures at 6-24 months³ 
    • In a distal radius case report, at 6 weeks, an elderly patient with multiple risk factors and comorbidities with a distal radius fracture completely healed in a dorsal bone void that was not grafted, and "healing was akin to a much younger person who had been grafted for an almost identical procedure"6

References

  1. K102597 – Piccolo Composite Plate System submitted by N.M.B Medical Applications, Ltd.
  2. Lee AK, Mitchell PM, Ziran BH, Jahangir AA.Early Comparative Outcomes of Continuous Carbon-Fiber Reinforced Polymer Plate in Fixation of Distal Femur Fractures. Paper #155. Presented at OTA 2017.
  3. Guzzini M, Lanzetti RM, Lupariello D, Morelli F, Princi G, Perugia D, Ferretti A. Comparison between carbon-peek plate and conventional stainless steel plate in ankle fractures. A prospective study of two years follow up. Injury. 2017 Jun;48960:1249-1252.
  4. Hak DJ, et al. Seeing is believing: treatment of proximal humerus fractures using a novel radiolucent implant and its effect on reduction accuracy, healing rate, and functional outcome. Paper #482. Presented at EFORT 2014 meeting. 
  5. Caforio M, Perugia D, Colombo M, Calori GM, Maniscalco P. Preliminary experience with Piccolo Composite™, a radiolucent distal fibula plate, in ankle fractures. Injury. 2014 Dec;45 Suppl 6:S36-S38. Doi: 10.1016/j.injury.2014.10.020. Operative time data included in earlier presentation by Pietro Maniscalco at 2014 AOFAS Meeting in Chicago, “Preliminary Experience with Carbofix – Radiolucent Distal Fibula Plate In Ankle Fractures.
  6. Rives AW. Case Study: Distal Radius Fracture. Invibio YouTube Channel. https://youtu.be/GjtbpAHshUw. Testimonials presented have been provided by practicing orthopedic surgeons.  Their view and experience are their own and do not necessarily reflect those of others.  “Invibio” disclaims any liabilities or loss in connection with the information herein.


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