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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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. Biorad Medisys Pvt Ltd. One patient sustained a patella fracture after a fall within the first year after surgery and in two cases tibial augmentation was necessary, which constituted a protocol violation.
Please refer to the other divisions of this site for specific procedures. None of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. Clin Orthop Relat Res. Statistical analysis Statistical analysis was performed with the use of SAS software v9. Please sign in to view this content Also, we reduced confounding factors by the use of two prostheses of similar design from the same manufacturer, consistent PCL status, inclusion of patients with the same form of arthritis and independent assessment of clinical and radiological outcome scores.
Journal List Int Orthop v.
There was also a statistically significant difference in preoperative scores between the groups, but no difference in postoperative scores. J Bone Joint Surg Br. Intra-operative flexibility Address an array of patient needs OR efficiency with common tibial base and preparation as used in higher constrained implant options Allows for bearing rotation that reduces torsional stresses on tibial base 1.
As in previous trials we found no statistically significant difference in overall range of motion between the groups. Registration is free and gives you unlimited access to all of the content and features of Which Medical Device. Their designs provide articulation at both the upper and lower surfaces of the bearing, improving congruency and thus leading to a reduction of polyethylene contact stresses. Many different designs for mobile bearings exist, based on a glide or rotating mechanism with uni- or multidirectional motion.
To date, however, there has been no convincing evidence that these theoretical advantages lead to an improvement in clinical outcomes and survivorship.
Based upon the clinically proven P. We carried out a randomised controlled trial comparing the functional outcome and survivorship between the fixed-bearing and rotating-platform PFC Sigma knee replacement systems. Comparison between mobile-bearing and depy knees in bilateral total knee replacements. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings.
Description From Depuy The P. No analysis for improvement in scores was reported.
pfv The authors showed no statistically significant difference in postoperative knee scores, but found statistically significantly better results for isokinetic muscle force in flexion and medio-lateral stability in flexion for the rotating bearing group.
We also did not encounter any bearing dislocations, which has been described as a potential complication of mobile-bearing implants in other studies [ 2627 ]. Patient-reported outcomes after fixed- versus mobile-bearing total knee replacement: CD [ PubMed ]. TKA is indicated for: The prostheses were found to be well fixed and without evidence of loosening in both cases.
This had the same sagittal, coronal and cam geometries as the Sigma CS but the radius from the anterior flange of the femoral component to the box for the tibial peg was increased, with the aim of reducing the risk of “patellar clunking” in the box eigma to change the tracking of the patellar component in flexion. The treatment allocation was concealed in sequentially numbered, sigm, sealed envelopes.
Depuy | PFC Sigma Knee System | Which Medical Device
If you would like to report a potential cybersecurity vulnerability in any of our products, please refer to our Responsible Disclosure Reporting website. Ten patients five in each group had a persisting fixed flexion deformity with a mean of 6. The implantation technique, however, was not consistent and the analysis included all-cement and hybrid femoral component uncemented fixation. Abstract The aim of this study was to deput whether there is a difference in functional outcome between the PFC Sigma fixed-bearing and rotating-platform total knee replacement systems.
The operation was ptc out through a midline incision using a medial parapatellar approach.
SIGMA® Total Knee System | DePuy Synthes Companies
Fixed-bearing versus mobile-bearing total knee arthroplasty: SIGMA continues a history of innovation based on clinical proof. Articles from International Orthopaedics are provided here courtesy of Springer-Verlag.
This is intended to substitute for the PCL without using a posterior stabilised component.