Analysis of Carbon Fiber Reinforced PEEK Hinge Mechanism Articulation Components in a Rotating Hinge Knee Design: A Comparison of In Vitro and Retrieval Findings

Schierjott, Ronja A.; Giurea, Alexander; Neuhaus, H J; Schwiesau, Jens; Pfaff, Andreas; Utzschneider, Sandra; Tozzi, Gianluca; Grupp, Thomas M.

doi:10.1155/2016/7032830

Cited by 16 publications

(4 citation statements)

References 45 publications

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“…The intraoperative findings of black debris in the tissue, from degraded carbon fiber of the CFR-PEEK implant bearing system, have also been reported in previous literature [16]. The CFR-PEEK design is included in Figure 11 for reference [27]. The carbon fiber debris of the implant has been found to lead to the component loosening and inflammation, correlating to the issues with joint function and pain/swelling experienced by the patients [1,16].…”

Section: Discussionsupporting

confidence: 54%

Early Failures of Total Knee Patients with Nickel Allergies Secondary to Carbon Fiber Debris

Maale¹,

Mohammadi²,

Kennard³

et al. 2020

TOORTHJ

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Aim: Currently, there are not many studies on the long-term outcomes of the specific implants used in patients with metal hypersensitivities. The purpose of this study is to report a significant number of TKA revision failures with the CFR-PEEK prosthetic knee implant with an anatomic hinge. Background: Patients can experience multiple issues following a primary Total Knee Arthroplasty (TKA). A growing body of research is finding a correlation between primary TKA failure and metal hypersensitivity, most commonly with nickel and cobalt. Because of this, knee prosthetics are being made from hypoallergenic metals, such as zirconium nitride (ZrN), to minimize the number of failures due to metal allergy. Given the relatively new development of the hypoallergenic prostheses, there is sparse data about their overall success. Objective: The purpose of this study is to report a significant number of TKA revision failures with the CFR-PEEK prosthetic knee implant with an anatomic hinge. Methods: In this study, we analyzed the sequelae of 84 patients between May 2015 to June 2020 who received a total knee revision due to a failed primary TKA with metal hypersensitivity. These patients were revised with the rotating anatomic hinge knee system, which consisted of Carbon Fiber Reinforced Poly-Ether-Ether-Ketone (CFR-PEEK implant) coated with a ZrN, Zirconium, and Chrome Nitride multi-layer surface coating with 30% polyacrylonitrile fiber content. The patients requiring an additional revision operation presented with increasing pain that showed evidence of osteolysis on plain radiographs, CT imaging, positive indium labeled WBC scans and increased uptake on bone scan. Intraoperatively, an open incisional biopsy of the surgical bed was obtained, followed by radical debridement and implantation of porex knee prosthesis. In addition, intraoperative findings included black debris that grossly stained the surrounding synovial tissue black, indicative of wear and debris from carbon fiber bearings and the anatomic hinge. Histology of the intraoperative biopsy showed the accumulation of black debris in the histiocyte, fibrosis, and perivascular cuffing of lymphocytes and multinucleated giant cells stained with black debris. Results: Of the 84 patients, 22 failed, requiring an additional revision procedure, equating to a 26 percent failure rate of the CFR-PEEK implant, averaging 25 months to failure. Conclusion: This study was meant to report the extremely high failure rate of the anatomic hinge secondary to carbon fiber debris. Perhaps carbon fiber-laden implants are not as good an option for total knee revision prosthesis because of the high failure rate compared to those with polyethylene in their hinge mechanism.

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Section: Discussionsupporting

confidence: 54%

Early Failures of Total Knee Patients with Nickel Allergies Secondary to Carbon Fiber Debris

Maale¹,

Mohammadi²,

Kennard³

et al. 2020

TOORTHJ

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“…PE inserts are available in 10 to 24 mm thickness. The axes are embedded in bushings and flanges made of CRF-PEEK, a novel biomaterial introduced as bearing articulation in knee arthroplasty for the first time aiming to minimize wear [ 22 , 23 ]. The prosthesis is designed for a ROM from 3° of hyperextension to 140° of flexion and allows a rotation of ±12°.…”

Section: Methodsmentioning

confidence: 99%

Midterm Results of a New Rotating Hinge Knee Implant: A 5-Year Follow-Up

Böhler

Kolbitsch

Schuh

et al. 2017

BioMed Research International

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Background In the current study, we investigated midterm results of a new rotating hinge total knee arthroplasty (EnduRo prosthesis), which uses a new bearing material (CFR PEEK). Methods We prospectively analysed data of 50 patients with a minimum follow-up of 5 years. In 24 (48%) patients, a primary implantation was performed and 26 (52%) were revision cases. Clinical and radiographic examinations were performed preoperatively as well as postoperatively after 3 and 12 months and annually thereafter. The Knee Society Score (KSS), WOMAC, Oxford Knee Score (OKS), and range of motion (ROM) were used for clinical assessment. Results KSS, WOMAC, OKS, and ROM significantly improved between the preoperative and the follow-up investigations. The overall survival rate with revision for any reason as an endpoint was 77.9% after five years. The number of complications was significantly higher in the revision group (p = 0.003). Conclusion The EnduRo prosthesis provides highly satisfying clinical and functional results in severe primary as well as in revision cases. Implant-associated complications were rare. However, in cases of revision surgery, the risk for complications was considerably high, mostly related to previous joint infections and poor soft tissue quality.

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“…In an in vitro wear study, the ZrN multilayer coating was able to reduce the amount of CFR-PEEK wear particles produced from the flanges and flexion axis in comparison to the uncoated CoCrMo version of the implant by more than 90% [53]. A study on retrievals with an in vivo service between 12 and 60 months has confirmed the wear patterns on the CFR-PEEK components seen during the in vitro wear simulation test [69].…”

Section: Wear Against Cfr-peekmentioning

confidence: 56%

Modern Coatings in Knee Arthroplasty

Lützner¹,

Altermann²,

Reyna³

et al. 2023

Arthroplasty - Advanced Techniques and Future Perspectives

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All metal implants in human bodies corrode, which results in metal ion release. This is not necessarily a problem and represents for most patients no hazard. However, both local and systemic effects are possible, including hypersensitivity. To avoid this, coatings on standard implants (mono- or multi-layer) and surface modifications have been developed and are in use. This chapter explains the background of metal ion release, biological reactions, coating technologies, biotribological and biomechanical properties, as well as the clinical results of modern knee arthroplasty implant coatings. There is no general concern about metal ion release from CoCrMo standard implants for most patients. If patients present with a confirmed metal allergy, a multilayer-coated or oxidized zirconium implant is currently the best option for these patients.

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Analysis of Carbon Fiber Reinforced PEEK Hinge Mechanism Articulation Components in a Rotating Hinge Knee Design: A Comparison of In Vitro and Retrieval Findings

Cited by 16 publications

References 45 publications

Early Failures of Total Knee Patients with Nickel Allergies Secondary to Carbon Fiber Debris

Early Failures of Total Knee Patients with Nickel Allergies Secondary to Carbon Fiber Debris

Midterm Results of a New Rotating Hinge Knee Implant: A 5-Year Follow-Up

Modern Coatings in Knee Arthroplasty

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