Healthcare professionals - Trauma

Advanced Treatment with Non-metal Trauma Devices

Potential clinical advantages with <span class="nowrap">PEEK-OPTIMA</span> Ultra-Reinforced Polymer, a carbon fiber composite
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A Non-metal Alternative for Trauma Fixation

Offering a powerful combination for healing when complications related to non-unions, delayed unions and implant failures continue to be a challenge1 – especially in high risk patient populations.2-4

50x GREATER FATIGUE RESISTANCE5

Carbon fiber composite, PEEK-OPTIMA™ Ultra-Reinforced may provide an increased window of opportunity for healing to occur, compared to metal

150% GREATER CALLUS FORMATION6

Pre-clinical testing demonstrated earlier and greater callus formation which may improve secondary bone healing compared to metal with the carbon fiber composite material, PEEK-OPTIMA Ultra-Reinforced

360° FRACTURE VISIBILITY

PEEK-OPTIMA Ultra-Reinforced, a carbon fiber composite, offers circumferential visibility of the fracture site during and after the procedure for post-operative surveillance

References

  1. Henderson CE et al. Locking plates for distal femur fractures: is there a problem with fracture healing? J Orthop Trauma. 2011 Feb;25 Suppl 1:S8-14.doi: 10.1097/BOT.0b013e3182070127
  2. Ng M et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980—2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014; 384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8
  3. Danaei G et al. National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants. Lancet. 2011 Jul; 378(9785):31-40. doi: 10.1016/S0140-6736(11)60679-X.
  4. International Osteoporosis Foundation Facts and Statistics Website. http://www.iofbonehealth.org/facts-statistics Accessed September 15, 2014.
  5. Data on file at Invibio. Mechanical Benchmark of Carbon Fiber PEEK-OPTIMA Ultra-Reinforced vs Ti 6AI-4V Plates Undergoing Static and Dynamic Testing per ASTM F382-99 (2008).
  6. Jo Wilson, PhD, Matthew Cantwell; Polyether Ether Ketone (PEEK) Carbone Fiber Composites May Improve Healing of Fractures Stabilized with Intramedullary Nails. (Basic Science Focus Forum, paper #4, 2014) 155.

Trauma Applications

Our proven, biocompatible carbon fiber composite material, PEEK-OPTIMA Ultra-Reinforced polymer may offer the potential to enhance healing in challenging patients. Read more about the applications where this innovative material is currently utilized.

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PEEK-OPTIMA™ polymers

PEEK-OPTIMA™ polymer blends proven performance with superior wear, safety and comfort. Since Invibio introduced PEEK-OPTIMA as the first implantable PEEK polymer in 1999, it has earned the confidence and gained the acceptance of the global medical community.

PEEK-OPTIMA™ Ultra-Reinforced

PEEK-OPTIMA™ Ultra-Reinforced

For over 15 years and approximately 9M devices implanted worldwide, the high-performance implant-grade polymer, PEEK-OPTIMA Natural has been utilized in spinal fusion applications, predominantly in the form of load-bearing interbody fusion devices. With continued innovation PEEK-OPTIMA Natural polymer is reinforced with carbon fibers, forming a composite material where the stiffness can be tailored, resulting in treatment options that are less rigid than equivalent all metal constructs.1 The result is an ultra-strong alternative to metal traditionally used in internal fracture fixation procedures.

Metal has been used for internal trauma fixation for decades, with generally good outcomes. However, complications related to non-unions, delayed unions and implant failure continue to be a challenge3 – especially for higher risk patients. Now there is a material with greater fatigue life that may extend the time before implant failure and increase the potential for healing.2 Compared to metal, PEEK-OPTIMA Ultra-Reinforced polymer provides:

  • Tailored stiffness1
  • Similar mechanical strength1
  • Greater material fatigue life1
  • Earlier and greater callus formation2
  • Radiolucency and artifact-free imaging
  • Increased accuracy of radiotherapy dosing in cancer patients4

Compared to metals typically used in anatomic trauma plates, PEEK-OPTIMA Ultra-Reinforced polymer may provide:

  • 50x Greater Fatigue Resistance1 – increasing the window of opportunity to union
  • 150% Greater Callus Formation2 – which may improve secondary healing
  • 360° Fracture Visibility – for insight during reduction and postoperatively
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References

  1. Data on file with Invibio – Mechanical Benchmark of Carbon Fiber PEEK-OPTIMA Ultra-Reinforced vs Ti 6AI-4V Plates undergoing Static and Dynamic Testing per ASTM F382-99 (2008)
  2. Jo Wilson, PhD; Matthew Cantwell; Polyetheretherketone (PEEK) Carbon Fiber Composites May Improve Healing of Fractures Stabilized with Intramedullary Nails. (Basic Science Focus Forum, paper #4, 2014) 155
  3. CE Henderson et al. Locking plates for distal femur fractures: is there a problem with fracture healing? (J Orthop Trauma, 2011 Feb 25) Suppl 1:S8-14.doi: 10.1097/BOT.0b013e3182070127
  4. Biagini, 2014. The Use of Carbon-Fiber Reinforced PEEK Orthopedic Devices and Implants in Cancer Patients Who Undergo Radiotherapy: A Report From the Italian Orthopaedic Society (SIOT) Bone Metastasis Study Group.
PEEK-OPTIMA™ Reinforced

PEEK-OPTIMA™ Reinforced

PEEK-OPTIMA Reinforced polymer consists of short carbon fibers dispersed within the PEEK-OPTIMA Natural matrix to provide properties well suited for distal radius, proximal humerus and other extremity plates. The resulting material has enhanced mechanical and physical properties for more demanding load-bearing implants and applications.

Selected published studies demonstrate:

  • Improved functional outcomes vs. conventional locking plates
    • Significantly better outcome scores (OSS and CMS) at 2 year follow-up for patients treated a CFR-PEEK proximal humerus plate vs. patients treated with a conventional locking plate1
  • Fewer complications vs. conventional locking plate
    • Loss of reduction with subsequent varus deformity less frequently observed in patients treated with a CFR-PEEK proximal humerus plate vs. a conventional locking plate1
    • No cases of hardware breakage or loss of reduction at 12-month follow-up in patients treated with a distal radius plate2 and no cases of fatigue failure with proximal humerus3
    • Visibility in all radiographic planes of cortices and screws with potential to improve surgical technique, follow-up clinical assessment,2,3 and reduce the risk of primary screw perforation1
    • Limited osseointegration, facilitating plate removal2
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References

  1. Schleimann B et al. Treatment of proximal humerus fractures with a CFR-PEEK plate: 2-year results of a prospective study and comparison to fixation with a conventional locking plate. J Shoulder Elbow Surg. 2015 Aug;24(8):1282-8. doi: 10.1016/j.jse.2014.12.028
  2. Tarallo L et a. A new volar plate made of carbon-fiber-reinforced polyetheretherketone for distal radius fracture: analysis of 40 cases. J Orthop Traumatol. 2014 Dec;15(4):277-83. doi: 10.1007/s10195-014-0311-1
  3. Rotini R. Proximal humeral fracture fixation: multicenter study with carbon fiber peek plate. Musculoskelet Surg. 2015 Sep;99 Suppl 1:S1-8. doi: 10.1007/s12306-015-0371-2.

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