Patients with rheumatoid arthritis and patients undergoing revision arthroplasty, requiring tibial component augmentation or a constrained prosthesis were excluded from the study.
TKA is indicated for: Indus HiFlex Knee Manufacturer: We also did not encounter any bearing dislocations, which has been described as a potential complication of mobile-bearing implants in other studies [ 2627 ]. Description From Depuy The P. A multicentre single-blind randomised controlled trial. Simulator studies have shown that this significantly lowers the wear rate compared to standard fixed-bearing knee replacements [ 2 ].
Results may therefore not be transferable to a western European population.
The theoretical advantages of a mobile bearing design are attractive, but there has been no convincing evidence that these theoretical advantages translate into a benefit for the patient and deliver a better outcome in the short or long terms. Long-term follow-up will determine if there is an increased rate of wear or loosening in either group.
Since publication of the Cochrane review dpeuy studies have been reported, comparing mobile and fixed-bearing knee replacement systems.
To date, however, there has been no convincing evidence that these theoretical advantages lead to an improvement in clinical outcomes and survivorship. Our randomised controlled trial of patients who underwent unilateral knee replacement for osteoarthritis showed no statistically significant difference in functional outcome and survivorship between the mobile-bearing and rotating-platform in the PFC Sigma total knee replacement at a mean of Keep up to date Subscribe to our sjgma.
In these studies a variety of knee replacements have been used, but often prostheses of different design and different manufacturers were compared with each other [ 6 — 10 ].
This is intended to substitute for the PCL without using a posterior stabilised component. In all patients a posterior-stabilised implant was used and the patella resurfaced.
For the subsequent patients a further randomisation schedule, blocked and stratified for treatment only, was produced by sigm biostatistician at DePuy International Ltd.
Please sign in to view this content They allow a more natural tibial rotation during flexion than fixed-bearing implants. Please refer to the other divisions of this site for specific procedures. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Similar Devices of SIGMA continues a history of innovation based on clinical proof. Resources Bespoke Report P. COVERNOX Antioxidant stabilizes free radicals and prevents oxidation 4 Addition of an antioxidant eliminates the need for a heat treatment, thus maintains excellent mechanical properties 4 Moderate levels of cross-linking for wear performance similar to XLK.
Intra-operative flexibility Common instrumentation if need to increase levels of constraint Addresses an array of patient needs.
The primary outcome measure was active range of motion ROM at one year after surgery. The PCL was retained in all patients, but neither patella resurfacing status nor implant fixation technique have been reported.
The prostheses were found sigmz be well fixed and without evidence of loosening in both cases. We ask that our members register with us so that we can maintain the unbiased and independent nature of our content.
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Depuy | PFC Sigma Knee System | Which Medical Device
All patients received perioperative antibiotic and thromboprophylaxis. Mobile versus fixed-bearing total knee arthroplasty: These findings were reiterated in a meta-analysis by Oh et al.
There was no statistically significant difference in clinical and radiological outcomes between the groups at a mean of 7. Your opinion matters to others – rate this device or add a comment. Ten patients five in each group had a persisting fixed flexion deformity with a mean of 6. Four patients were randomised to a mobile-bearing, but received a fixed-bearing implant due to problems with implant availability.
The most recent randomised controlled trial by Higuchi et pfcc. Journal List Int Orthop v. There was also a statistically significant difference sigmq preoperative scores between the groups, but no difference in postoperative scores. The strengths of this study include its design as a randomised controlled trial with adequate power.
Weight-bearing X-rays were taken immediately and one year post surgery to determine the incidence of osteolysis and loosening. The PCL was retained and the patella resurfaced in all patients.