Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
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Proc Inst Mech Eng H · Oct 2007
Clinical TrialFluoroscopy-based navigation system in spine surgery.
The variability in width, height, and spatial orientation of a spinal pedicle makes pedicle screw insertion a delicate operation. The aim of the current paper is to describe a computer-assisted surgical navigation system based on fluoroscopic X-ray image calibration and three-dimensional optical localizers in order to reduce radiation exposure while increasing accuracy and reliability of the surgical procedure for pedicle screw insertion. Instrumentation using transpedicular screw fixation was performed: in a first group, a conventional surgical procedure was carried out with 26 patients (138 screws); in a second group, a navigated surgical procedure (virtual fluoroscopy) was performed with 26 patients (140 screws). ⋯ The radiation running time for each vertebra level (two screws) reached 3.5 s on average in the computer-assisted group and 11.5 s on average in the non computer-assisted group. The operative time for two screws on the same vertebra level reaches 10 min on average in the non computer-assisted group and 11.9 min on average in the computer-assisted group. The fluoroscopy-based (two-dimensional) navigation system for pedicle screw insertion is a safe and reliable procedure for surgery in the lower thoracic and lumbar spine.
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Proc Inst Mech Eng H · Aug 2007
Comparative StudyMeasurement of laxity in the anterior cruciate ligament-deficient knee: a comparison of three different methods in vitro.
The aim of this study was to compare in-vitro measurements of anteroposterior laxity in the anterior cruciate ligament (ACL)-deficient knee using three different methods: an Instron materials-testing machine, then a KT-2000 arthrometer, and finally by Roentgen stereophotogrammetric analysis (RSA). Eight ACL-deficient human cadaver knees were used. Total displacement was measured between 90 N anterior and 90 N posterior tibiofemoral drawer forces at both 20 degrees and 90 degrees knee flexion. ⋯ However, the mean Instron measurements of laxity were significantly (3-4 mm) higher than both RSA and KT-2000 measurements. The clinical methods of RSA and the KT-2000 measurements agreed well but appeared to underestimate tibiofemoral anteroposterior laxity compared with the materials-testing machine. These findings may be helpful in the future comparison of different studies.
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Calcium phosphate cement (CPC) sets to form hydroxyapatite, a major component of mineral bone, and is gaining increasing interest in bone repair applications. However, concerns regarding its brittleness and tendency to fragment have limited its widespread use. In the present study, short-fibre reinforcement of an apatitic calcium phosphate has been investigated to improve the fracture behaviour. ⋯ Fibre addition of up to 10 wt % had a significant effect on composite properties, with the energy absorbed during failure being significantly increased, although this tended to be accompanied with a slight drop in compressive strength. The fibre reinforcement mechanisms appeared to be crack bridging and fibre pull-out. The setting time of the CPC with fibre reinforcement was also investigated and was found to increase with fibre volume fraction.
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Proc Inst Mech Eng H · Jan 2007
ReviewDevelopment and clinical application of meniscal unicompartmental arthroplasty.
About one-third of osteoarthritic patients requiring knee replacement have focal lesions limited mainly to the medial compartment and can achieve excellent postoperative function after medial unicompartmental replacement. However, late failures of many unicompartmental prostheses require revision at a rate about twice that of total knee replacement. The use of a fully conforming mobile-bearing meniscal unicompartmental prosthesis in the hands of experienced surgeons can reduce revision rates to levels equivalent to the best results achieved with total knee replacement. The paper argues the case for such a prosthesis and demonstrates that the usual modes of failure of unicompartmental arthroplasty, most of them biomechanical, can thereby be avoided.
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Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. ⋯ The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.