Bone ingrowth into porous silicon nitride
Achieving solid skeletal attachment is a requirement for the clinical success of orthopedic implants. Porous or roughened surfaces and coatings have been developed and used with mixed success to achieve attachment due to bone ingrowth. Silicon nitride is a high performance ceramic whose strength, imaging properties, and biocompatibility make it a candidate material for orthopedic implants. A porous form of silicon nitride, cancellous-structured ceramic (CSC), has been developed. CSC is a nonresorbable, partially radiolucent porous structure that can be bonded to orthopedic implants made of silicon nitride to facilitate skeletal attachment. The purpose of this study was to quantify the extent and rate of bone ingrowth into CSC in a large animal model. Cylindrical implants were placed bilaterally using staged surgeries in the medial femoral condyle of six sheep. Condyles were retrieved after 3 and 6 months in situ and prepared for examination of bone growth under SEM. Bone grew into CSC to extents and at rates similar to those reported for other titanium porous surfaces in studies involving large animals and postmortem retrievals in humans. Bone ingrowth was observed at depths of penetration greater than 3 mm in some implants after only 12 weeks in situ. Bone ingrowth into CSC is a viable method for achieving skeletal attachment.
Available from: Mark P Arts
- "Moreover, the CSC material fills the center hole for the purpose of providing a scaffold for bone ingrowth resulting in solid fusion and no subsidence of the cage. The CSC form of the material has performed well in an animal model  but the results and effectiveness need to be validated in humans. It is possible that solid fusion without signs of subsidence may lead to improved clinical outcome. "
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ABSTRACT: Anterior cervical discectomy with interbody fusion cages is considered the standard surgical procedure in patients with cervical disc herniation. However, PEEK or metal cages have some undesirable imaging characteristics, leading to a search for alternative materials not creating artifacts on images; silicon nitride ceramic. Whether patients treated with silicon nitride ceramic cages have similar functional outcome as patients treated with PEEK cages is not known. We present the design of the CASCADE trial on effectiveness of ceramic cages versus PEEK cages in patients with cervical disc herniation and/or osteophytes.Methods/design: Patients (age 18--75 years) with monoradicular symptoms in one or both arms lasting more than 8 weeks, due to disc herniation and/or osteophytes, are eligible for the trial. The study is designed as a randomized controlled equivalence trial in which patients are blinded to the type of cage for 1 year. The total follow-up period is 2 years. The primary outcome measure is improvement in the Neck and Disability Index (NDI). Secondary outcomes measures include improvement in arm pain and neck pain (VAS), SF-36 and patients' perceived recovery. The final elements of comparison are perioperative statistics including operating time, blood loss, length of hospital stay, and adverse events. Lateral plane films at each follow-up visit and CT scan (at 6 months) will be used to judge fusion and the incidence of subsidence. Based on a power of 90% and assuming 8% loss to follow-up, 100 patients will be randomized into the 2 groups. The first analysis will be conducted when all patients have 1 year of follow-up, and the groups will be followed for 1 additional year to judge stability of outcomes.
While the new ceramic cage has received the CE Mark based on standard compliance and animal studies, a randomized comparative study with the golden standard product will provide more conclusive information for clinicians. Implementation of any new device should only be done after completion of randomized controlled effectiveness trials.
Available from: G. Amato
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ABSTRACT: A facile fabrication method to produce biocompatible semiconductor Quantum Dots encapsulated in high quality and thick thermal oxide is presented. The process employs sonication of porous Si/SiO2 structures to produce flakes with dimension in the 50-200 nm range. These flakes show a coral-like SiO2 skeleton with Si nanocrystals embedded in and are suitable for functionalization with other diagnostic or therapeutic agents. Silicon is a biocompatible material, efficiently cleared from the human body. The Photoluminescence emission falls in the transparency window for living tissues and is found to be bright and stable for hours in the aggressive biological environment.
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