SIGMA® Primary Knee System Balanced Surgical Technique DePuy Synthes Joint Reconstruction 2 DePuy Synthes Joint Reconstruction SIGMA® Primary Knee System Balanced Surgical Technique PFC Chamfer Guides Size Product, DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, . Functional outcome of PFC Sigma fixed and rotating-platform total knee . system (PFC Sigma or PFC Sigma RP, DePuy, Warsaw, Indiana).
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Simultaneous mobile- and fixed-bearing total knee replacement in the same patients. All medical devices have associated risks. SIGMA is designed to address implant longevity by maximizing femoro-tibial contact area, minimizing peak contact stresses while employing state-of-the-art polyethylene sterilization and packaging.
Assuming a two-sample t -test was used for the primary analysis, 48 patients in each treatment group were needed to identify a degree difference based upon a significance level of 0. Sigmq flexibility Common instrumentation if need to increase levels of constraint Addresses an array of patient needs. Total knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
All implants were posterior stabilised, cemented dpeuy the patella was resurfaced in all cases. The patella was not resurfaced. Simulator studies have shown that this significantly lowers the wear rate compared to standard fixed-bearing knee replacements [ 2 ]. All operating surgeons were experienced in the use of the PFC Sigma knee system and its instrumentation. To our knowledge no prospective study has been published comparing these two designs without resurfacing of the patella using posterior cruciate ligament PCL retaining implants.
In the postoperative period nine patients experienced complications.
Depuy | PFC Sigma Knee System | Which Medical Device
Please refer to the other divisions of this site for specific procedures. There was however no difference in ROM at four years between the groups. Highly polished cobalt chrome tibial tray provides smooth surface to minimize polyethylene wear 1 i2 locking mechanism with an interference fit for decreased micromotion 2 Features XLK polyethylene, a moderately cross-linked, oxidatively stable material.
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.
Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. One hundred twenty patients were randomised to receive either a fixed-bearing or rotating-platform PFC Sigma total knee replacement. The sample size was calculated based on detecting a difference of 20 degrees in the postoperative range of motion ROM between the fixed- and mobile-bearing knee systems.
Your opinion matters to others – rate this device or add a comment. P -values of less than 0. There was no evidence of osteolysis or loosening in either of the groups and no revision for infection or implant failure.
The rotating platform, as used in the PFC Sigma RP knee replacement system, has unidirectional motion which has been shown to have less volumetric wear than other mobile designs [ 12 ]. The operation was carried out through a midline incision using a medial parapatellar approach.
Based upon the clinically proven P. These include randomised controlled trials [ 6 — 815 — 1723 ], prospective case series [ 910 ] and retrospective reviews [ 12 — 1424 ].
Registration is quick and free. Accessed 30 Oct Sigja patients five in each group had a persisting fixed flexion deformity with a mean of 6.
Statistical analysis Statistical analysis was performed with the use of SAS software v9. Total Knee System introduced inP.
A multicentre single-blind randomised controlled trial. The most recent randomised controlled trial by Higuchi et al. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Click here to visit http: Overview of published studies comparing fixed-bearing and rotating-platform PFC Sigma knee replacement systems.
Based on the current results no type of bearing can be recommended over the other. J Bone Joint Surg Am. Four patients were randomised to a mobile-bearing, but received a fixed-bearing implant due to problems with implant availability.
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 ]. Mobile versus fixed-bearing total knee sivma Find out more here.
Depuy | PFC Sigma Knee System
It has also been suggested that mobile bearings minimise stress at the tibial bone—prosthesis aigma [ 3 ]. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings.
The patella was not replaced in either group. A clinical assessment was carried out preoperatively and at a minimum of one year after surgery. Total Knee Arthroplasty TKA and Unicompartmental Knee Replacement are intended to provide increased patient mobility and reduce pain by replacing the damaged knee joint articulation in patients depug there is evidence of sufficient sound bone to siyma and support the components.
Range of motion was measured using a goniometer with the patient in the supine position. None of these studies sigm a statistically significant difference between the mobile and fixed bearing, but the use of different types and designs of implants may have affected the clinical outcome as has previously been acknowledged by Biau et al. If you would like to report a potential cybersecurity vulnerability in any of our products, please refer to our Responsible Disclosure Reporting website.
They allow a more natural tibial rotation during flexion than fixed-bearing implants. There was no statistically significant difference in clinical and radiological outcomes between the groups at a mean of 7.