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Advanced Treatment with Non-metal Trauma Devices
Potential clinical advantages with <span class="nowrap">PEEK-OPTIMA™</span> Ultra-Reinforced Polymer, <br/>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-OPTIMATM Ultra-Reinforced
360° FRACTURE VISIBILITY
PEEK-OPTIMATM 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.
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.
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.
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.
evidence in trauma solutions
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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Contact an expertPEEK-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 has gained the acceptance of the global medical community.
PEEK-OPTIMA™ Ultra-Reinforced
PEEK-OPTIMA™ Ultra-Reinforced
With continued innovation PEEK-OPTIMATM 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 challenge2 – 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.3 Compared to metal, PEEK-OPTIMA Ultra-Reinforced polymer provides:
- Tailored stiffness1
- Similar mechanical strength1
- Greater material fatigue life1
- Earlier and greater callus formation3
- 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 Formation3 – which may improve secondary healing
- 360° Fracture Visibility – for insight during reduction and postoperatively
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. 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.
3. 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.
4. Biagini R. 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. Presented at EFORT, June 2014.
PEEK-OPTIMA™ Reinforced
PEEK-OPTIMA™ Reinforced
PEEK-OPTIMA Reinforced polymer consists of short carbon fibers dispersed within the PEEK-OPTIMATM 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 versus conventional locking plates
- Significantly better outcome scores (OSS and CMS) at 2 year follow-up for patients treated with a CFR-PEEK proximal humerus plate versus patients treated with a conventional locking plate1
- Fewer complications versus conventional locking plate
- Loss of reduction with subsequent varus deformity, less frequently observed in patients treated with a CFR-PEEK proximal humerus plate versus 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 plate,2 and no cases of fatigue failure with proximal humerus plate3
- 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
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.
2. Tarallo L, et al. 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.
3. Rotini R. Proximal humeral fracture fixation: multicenter study with carbon fiber peek plate. Musculoskelet Surg. 2015 Sep;99 Suppl 1:S1-8.
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