The femoral and tibial AP and ML values obtained from each patient were compared with the sizes of available knee implants. The femur sizes were compared with PFC Sigma (Depuy, Warsaw, IN, USA), Attune (Depuy), Triathlon (Stryker, Kalamazoo, IN, USA), Nexgen (Zimmer, Warsaw, IN, USA), and Vanguard (Biomet, Warsaw, IN, USA). The tibial sizes were compared with PFC Sigma (Depuy), Attune (Depuy), Nexgen (Zimmer), and Vanguard (Biomet). Scatter graphs were plotted with the patient size and the best possible implant size for all the implants.
Pfc sigma
Manufactured by DePuy
Sourced in United States
The PFC Sigma is a medical device used in orthopedic procedures. It is designed to provide stable fixation and facilitate the healing process. The product's core function is to serve as a component in joint replacement surgeries, assisting in the restoration of joint function.
Automatically generated - may contain errors
Lab products found in correlation
Genesis 2, by Smith & Nephew (3 mentions)
Triathlon, by Stryker (3 mentions)
Vanguard, by Zimmer Biomet (2 mentions)
Nexgen, by Zimmer Biomet (2 mentions)
Pinnacle corail, by DePuy (1 mentions)
Corail, by DePuy (1 mentions)
Pinnacle cup, by DePuy (1 mentions)
Trilock stem, by DePuy (1 mentions)
Duracon, by Stryker (1 mentions)
Attune, by DePuy (1 mentions)
11 protocols using pfc sigma
1
Optimal Knee Implant Selection
2
Total Joint Arthroplasty Protocol for Hemophilia Patients
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One surgical team consisting of 2 senior orthopaedics surgeons performed all TJAs. The surgeons applied a standard posterolateral approach as previously described [10 (link)] for the patients undergoing THA, using the cementless prostheses (DePuy PINNACLE+CORAIL). For patients undergoing TKA, a standard medial parapatellar approach and a measured resection technique were used as previously described [9 (link), 11 (link)], the prosthesis was a cemented total knee system (DePuy Sigma PFC). For patients in the TXA group, TXA was administered as described before [11 (link)]. Briefly, all patients in the TXA group received intravenous TXA 5 to 10 min before the skin incision (20 mg/kg) and 3, 6, 12, and 24 h later (10 mg/kg) along with 1 g of topical TXA in 50 mL of normal saline solution. Tourniquet was used in all patients undergoing TKA. The surgeons applied the same modern perioperative pain control, clinical and rehabilitation protocols in all patients as previously described [9 (link)–11 (link)]. Considering the characteristic of haemophilia patient, only mechanical methods including compression elastic stockings and intermittent pneumatic compression were used for prophylaxis.
3
Quantifying Knee Prosthesis and Bone Cement
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We defined bone and soft tissues removed during the operation as the removed material and the knee prosthesis and bone cement as the implanted material. The removed material and residual polymerized cement were collected using two specimen bags during the operation and then weighed using a precision electronic balance with an accuracy of 0.0001 g (Fig. 1 c-d). The manufacturers provided the weight of the specimen bags, prostheses, and one full bottle of cement. The weight of the bone cement in the whole bottle minus the weight of the unused cement was calculated as the weight of the used bone cement. We defined the change of the knee joint weight as the total weight of the implanted material minus the total weight of the removed material.
In order to eliminate the influence of different implants on the postoperative efficacy of patients, all knees received cruciate-retaining (CR) implants (Sigma PFC®, DePuy, America). Otherwise, patients were excluded from this study. The femoral and tibial parts of the prostheses of this brand were made of cobalt-chromium (Co-Cr) alloy, and the spacer was made of highly cross-linked polyethylene.
In order to eliminate the influence of different implants on the postoperative efficacy of patients, all knees received cruciate-retaining (CR) implants (Sigma PFC®, DePuy, America). Otherwise, patients were excluded from this study. The femoral and tibial parts of the prostheses of this brand were made of cobalt-chromium (Co-Cr) alloy, and the spacer was made of highly cross-linked polyethylene.
4
Comparative Analysis of TKA Prostheses
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Retrospective analysis of the results of two groups of patients operated by the same surgeon by two primary PS TKA systems, PFC Sigma (DePuy Synthes, Johnson and Johnson®) and Genesis II prosthesis (Smith and Nephew®), with an average of five year follow-up was done. The demographic data of the patients including the preoperative co-morbidities are shown in (Table 1 ).
Demographic data of the patients
| Variable | Group 1 (152 knees) | Group 2 (122 knees) | p-value |
|---|---|---|---|
| Age (years) | 68.2 ± 6.5, (55–81) | 67.1 ± 6, (56–80) | 0.151 |
| Male/female | 41/111 | 35/87 | 1.000 |
| Duration of follow-up (years) | 5.2 ± 2.1, (3.5–6.2) | 5.0 ± 2, (3.2–5.6) | 0.424 |
| Body mass index | 28.1 ± 2.5 | 27.8 ± 3.1 | 0.387 |
Preoperative co-morbidities* Hypertension Diabetes Heart disease Thyroid disease Chronic kidney disease BPH Spinal decompression Lupus erythematosus Previous cancer colon Previous breast cancer Post-phlebitic limb Depression | 83 74 62 13 8 5 3 0 1 2 1 10 | 67 45 34 10 7 5 4 2 0 3 0 11 |
*Heart disease includes patients with previous coronary bypass grafting; chronic kidney patients do not include patients with dialysis; previous spinal decompression patients do not include patients with radicular lower limb pain
5
Revision Knee Arthroplasty Protocols
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In the primary group, nine patients had a PFC Sigma (DePuy Synthes, West Chester, Pennsylvania, USA) and two had a Triathlon (Stryker, Kalamazoo, Michigan, USA). In the fibrosis cohort, the primary knee arthroplasties were PFC Sigma in four cases, Triathlon in two, and Kinemax (Stryker Howmedica Osteonics, Mahwah, New Jersey, USA) in two. Four of the eight cases in this group had had the patella resurfaced during the primary procedure. In the non-fibrotic revision cohort the primary knee arthroplasties were PFC Sigma in two, Triathlon in one, and Kinemax in two. Revisions were performed using the NexGen rotating hinge (ZimmerBiomet, Warsaw, Indiana, USA; five cases), LCCK (ZimmerBiomet; five cases), and TC3 (DePuy Synthes; three cases).
In all primary and revision TKA patients, local anaesthetic was administered intraoperatively under direct vision (to a maximum dose of 100 ml of 0.2% ropivacaine). All patients were given routine postoperative analgesia, including regular paracetamol and a patient-controlled analgesia device. Patients in the fibrotic revision group were routinely started on continuous passive movement for 48 to 72 hours postoperatively.
In all primary and revision TKA patients, local anaesthetic was administered intraoperatively under direct vision (to a maximum dose of 100 ml of 0.2% ropivacaine). All patients were given routine postoperative analgesia, including regular paracetamol and a patient-controlled analgesia device. Patients in the fibrotic revision group were routinely started on continuous passive movement for 48 to 72 hours postoperatively.
6
Nationwide TKA Registry Data Analysis
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LROI TKA register data up to January 1, 2020 was obtained. All patients with primary osteoarthritis aged 18 years or older, with a primary TKA between January 1, 2014 and December 31, 2019, and who had PROM questionnaires available at all timepoints, were included. We included the 4 most commonly used TKA implants in the Netherlands: Genesis II (Smith and Nephew, Memphis, TN, USA), Nexgen (Zimmer Biomet, Warsaw, IN, USA), Vanguard (Zimmer Biomet, Warsaw, IN, USA), PFC/Sigma (DePuy Synthes, Warsaw, IN, USA). These total knee systems comprise 72% of all total knee implants used in the Netherlands between 2014 and 2019. The fifth most-used knee prosthesis in the Netherlands was the LCS (DePuy Synthes, Raynham, MA, USA); as only a limited proportion of patellae were resurfaced with this prosthesis (2.5%) and as it is no longer produced, the LCS was excluded from analysis.
7
Cementless THA and Cemented TKA
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All operations were performed in a single Department of Orthopaedic Surgery of a University Medical Centre. The lateral decubitus position was used for the cementless THA. A minimally invasive anterolateral approach was chosen [12 ]. Press-fit acetabular components and cementless stems from a single manufacturer (Pinnacle cup, Corail or Trilock stem; DePuy, Warsaw, IN) were used in all THAs. The cemented TKA was performed via a medial parapatellar approach. Cemented components from a single manufacturer (PFC Sigma; DePuy) were used in all TKAs. Patella resurfacing was not performed.
8
Multimodal Knee Arthroplasty Protocol
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All cases utilized a medial parapatellar incision and a multimodal pain management regimen. All patients were mobilized as soon as possible with no restrictions. Conventional implants (January 2008–December 2010) included the following models: Genesis 2 (Smith & Nephew), Sigma (DePuy), and PFC Sigma (DePuy). The PSI groups (January 2011–June 2013) received the ConforMIS iTotal G2 implant.
9
Prosthetic Knee Compatibility with Filipino Anatomy
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The currently available prostheses in the Philippine and Asian markets were reviewed. The dimensions of the prostheses and knees were plotted. The best fit line was used to observe the fitness of each prosthesis vis-à-vis the dimensions of the Filipino knee. The following implants were used for comparison: (1) Advance MPK (Microport Orthopedics, TN, USA); (2) Axis Knee (DOST-PCHRD, Philippines); (3) Duracon (Stryker Corp., MI, USA); (4) Gemini (Waldemar Link GmbH & Co., Germany); (5) Genesis II and Legion (Smith and Nephew, UK); (6) PFC Sigma (DePuy-Synthes, IN, USA); (7) Scorpio (Stryker Corp., MI, USA); and (8) U2 Knee (United Orthopaedics Corp., Taiwan). The aspect ratios of these prostheses were respectively based on the specifications provided by their corresponding companies.
10
Unilateral Cemented TKA with Femoral Nerve Block
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All patients underwent TKA with general anesthesia and a femoral nerve block. We performed unilateral cemented TKA (posterior-stabilized, n = 58; cruciate-retaining, n = 37; cruciate-substituting, n = 5) using a medial parapatellar or midvastus approach with a femoral tourniquet (300 mmHg). The types of implants used were the P.F.C. SIGMA (Depuy Synthes, Raynham, MA, USA) in 90 patients, Bi-Surface (Kyocera Medical Corporation, Osaka, Japan) in 3, Triathlon (Stryker Corporation, Kalamazoo, MI, USA) in 3, Vanguard (Zimmer Biomet, Warsaw, IN, USA) in 2, and Columbus (B/Braun Aesculap Implant Systems, Center Valley, PA, USA) in 2. A suction drain was placed in the joint. For postoperative pain management, the patients underwent placement of femoral nerve catheters with continuous infusion of 0.2% ropivacaine and oral administration of nonsteroidal anti-inflammatory drugs or acetaminophen. The femoral nerve catheter and suction drain were removed 2 days after surgery. All patients received antithrombotic treatment (edoxaban, a factor Xa inhibitor) for 2 weeks from the day after the operation.
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