Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial

Yang, Jingguo; Yuan, Yikai; Li, Xuepei; Yu, Hang; Guan, Junwen

doi:10.1136/bmjopen-2019-033997

Cited by 19 publications

(26 citation statements)

References 24 publications

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“…29,30 Finally, the implant material is characterized by higher biocompatibility and osseointegration as well as bonelike elasticity and strength, and it is also associated with lower susceptibility to infection. [31][32][33] Although artifacts due to the metal nature of the implant made it difficult to evaluate the postoperative MRI images, the use of different sequences on different planes and the comparison of pre-and postoperative images allowed us to rule out a residual or new compression of the cerebellum in all cases.…”

Section: Discussionmentioning

confidence: 99%

Occipital cranioplasty using customized titanium prosthesis yields successful outcome in association with foramen magnum decompression in dogs suffering by Chiari-like malformation

Colverde¹,

Nicetto²,

Falzone³

2022

ajvr

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OBJECTIVE To describe the use of a customized 3–D-printed titanium prosthesis as adjunctive treatment for foramen magnum decompression (FMD) in dogs with Chiari-like malformation (CM) and syringomyelia (SM). ANIMALS 8 dogs with clinical signs and MRI findings of CM-SM. PROCEDURES 3-D reconstruction of CT images of the head was used to simulate an occipital craniectomy and design the prosthesis. FMD was performed, and the prosthesis was implanted. Follow-up was performed 1, 6, and 12 months later, and clinical status was scored. Repeated MRI images were compared to identify changes involving the neural structures, particularly the syrinx. RESULTS All prostheses were easily positioned based on the preoperative 3-D models, with no complications. At 12 months after surgery, 3 dogs were free of previous medications, 4 were still receiving steroid medications but at lower doses, and 1 was occasionally receiving acupuncture. MRI of 5 dogs 6 to 20 months after surgery revealed resolution of SM (n = 1), reduced size of SM (3), or worse SM (1). All dogs showed an increase in size of the caudal cranial fossa. Dogs with a longer presurgical duration of the clinical signs and wider syrinx generally had worse outcomes than other dogs. CLINICAL RELEVANCE Findings suggested that use of customized 3–D-printed titanium prosthesis and associated FMD can represent an adjunctive option to medically treated dogs with CM-SM. Although the small number of cases precludes definitive conclusions, early surgical treatment, particularly in dogs with a small syrinx, could ensure better long-term outcomes, as previously suggested.

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Section: Discussionmentioning

confidence: 99%

Occipital cranioplasty using customized titanium prosthesis yields successful outcome in association with foramen magnum decompression in dogs suffering by Chiari-like malformation

Colverde¹,

Nicetto²,

Falzone³

2022

ajvr

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“…Patient-unique implants are a recent addition to available choices for cranioplasties [ 11 ]. These implants are created using computer-aided design and manufacture (CAD/CAM) based on patient's CT scan data and subsequently are 3D printed [ 5 , 9 , 11 , 12 ]. Synthes, Biomet, KLS Martin, OsteoMed, and OssDsign (Sweden) all report decreased operating times, better fits, and increased patient satisfaction with the use of PSI, but many of the MAUDE events report detailed intraoperative delays, in which the surgeon had to adjust the implant to achieve a better match to the patient’s defect [ 17 - 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…Even with this wide variety of options of inserts for cranioplasty surgeons, there has been little research performed describing complications of artificial cranioplasty plates after surgery [3,[7][8][9]. Therefore, this study aimed to provide a further assessment of post-operative complications of artificial cranioplasty plates after surgery by characterizing complications reported to a large federal database.…”

Section: Introductionmentioning

confidence: 99%

Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database

Hacherl¹,

Patel²,

Jones³

et al. 2021

Cureus

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IntroductionCranioplasty is performed by placing an artificial plate in place of a patient's native skull bones to repair post-craniectomy defects after trauma. Implanted materials can range from titanium to synthetic polyether derivatives and are produced by multiple manufacturers. There are few studies characterizing complications associated with these cranioplasty plates to date. We aimed to quantify and categorize complications of these devices using a national federal database. MethodsThe Manufacturer and User Facility Device Experience (MAUDE) database was queried for all entries reported under the category "plate, cranioplasty, preformed, non-alterable" with the additional product code GXN between the time range from September 1, 2010, to September 1, 2020. After data extraction, each of the entries was screened for duplicates and tabulated into different categories of complications. Additionally, product information such as the plate manufacturer was extracted from each entry. ResultsThe search yielded 329 unique event reports. The most frequent complications were infection (39%), followed by incorrectly fitting implants (30%) and implant breaks (6%). Other major complications included cerebrospinal fluid leakage and cerebral edema (5%), wound dehiscence (5%), and migration of hardware (3%). The brands associated with the most entries in the database were the Synthes (DePuy Synthes Companies, Massachusetts, United States) polyetheretherketone (PEEK) patient-specific implants (PSI) (57%), the Biomet (Zimmer Biome, Indiana, United States) hard tissue replacementpolyetherketoneketone (HTR-PEKK) patient-matched implant (PMI) (23%), and the AccuShape PEEK PSI (MedCAD, Dallas, USA) (5%). ConclusionsInfection and improperly fitting implants appear to be the two most frequent complications of cranioplasty plates. The goals of future research should include the prevention of plate infections as well as improving techniques to custom-fit implantable devices.

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“…An empiric antimicrobial treatment covering Gram-positive and Gram-negative germs was started. The appropriate response to therapy was ascertained and followed over time, monitoring systemic and local clinical signs [15]. Walcott et al [14] also reported that patient age, location of cranioplasty, presence of an intracranial device, bone flap preservation method and cranioplasty material were not predictive of the development of cranioplasty infection.…”

Section: Discussionmentioning

confidence: 99%

Cranioplasty: Surgical Research

Aboushehata

Abdelhameed

M.D.

et al. 2021

JAMMR

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Background: Cranioplasty involves the repair of a cranial defect or deformation for cosmetic reasons, as well as long-term protection of the brain from the external environment. This work aims to evaluate and compare the efficacy, advantages and limitations of different materials used in cranioplasty. Methods: Prospective study of twenty-five patients who underwent cranioplasty for a skull bone defect by using different materials from March 2018 to March 2020. Results: The study included 13 males and 12 females. The defect was post-traumatic in 11 patient neoplastic in 13 patients and 1 patient was after decompressive craniectomy for malignant ischemia .When the defect was less than 80 cm² bone cement was used in 54.5%. When the defect was ≥ 80 cm² titanium mesh was used in 71.4 % of those cases. 72.0% of the patients (18 of 25) reported excellent cosmetic results, 24% (6 of 25) good, 4.0% (1 of 25) poor results. Conclusion: When the original bone flap is not available for cranioplasty titanium mesh is suitable for the large calverial bone defects. it is strong but hard to shape while bone cement is more suitable for small defects near the skull base as it is easy to shape but weak. Medpore and hydroxyapetite powder are better for pediatric defects as they don't hinder bone growth. Prefabricated bone flaps are effective but expensive and can't be used if cranioplasty is planned in the same operation.

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Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial

Cited by 19 publications

References 24 publications

Occipital cranioplasty using customized titanium prosthesis yields successful outcome in association with foramen magnum decompression in dogs suffering by Chiari-like malformation

Occipital cranioplasty using customized titanium prosthesis yields successful outcome in association with foramen magnum decompression in dogs suffering by Chiari-like malformation

Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database

Cranioplasty: Surgical Research

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