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Refobacin bone cement r

Manufactured by Zimmer Biomet
Sourced in United States

Refobacin Bone Cement R is a sterile, radiopaque, self-curing bone cement composed of a powder component and a liquid component. The powder component contains polymethyl methacrylate, barium sulfate, and gentamicin sulfate. The liquid component contains methyl methacrylate monomer and N,N-dimethyl-p-toluidine.

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9 protocols using refobacin bone cement r

1

Patient-Specific Instrumentation for TKA

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All patients were operated on with a standard medial parapatellar approach using the Vanguard Cruciate Retaining Total Knee system (Vanguard Complete Knee System, Zimmer Biomet, Warsaw, IN, USA) and cemented with Refobacin Bone Cement R (Zimmer Biomet, Warsaw, IN, USA). PSPGs from Materialise NV (Leuven, Belgium) were used in this study. An MRI scan of the affected limb was uploaded to the implant manufacturer for implant positioning planning. Thereafter, an engineer working for the manufacturer of the PSPGs defined relevant anatomical landmarks from the uploaded MRI. A preoperative virtual operation plan was sent to the surgeon. The surgeon was free to change and adapt the preoperative virtual operation plan according to his/her expertise by manipulating the alignment in all 3 dimensions, the depth of the bone cuts, and the size of the implant. Once the surgeon was satisfied, the approved plan was sent back to the manufacturer, and the PSPGs were manufactured and delivered to the hospital.
75 of the operations were conducted by orthopedic surgeons who specialize in TKA. The operations were carried out by a resident under the guidance of an orthopedic surgeon in 2 cases. The surgical technique has been outlined in more detail in a previous publication on this RCT [9 (link)].
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2

Cemented GMK Sphere TKA Protocol

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A single series of 31 consecutive patients was recruited at Oslo University Hospital, Ullevaal, Oslo, Norway. The study protocol is shown in Table I and Figure 2. All patients received a cemented GMK Sphere TKA using Refobacin Bone Cement R (Zimmer Biomet, USA). One of two experienced surgeons performed all surgeries between April 2016 and February 2018. All patients underwent the same operative procedure and postoperative protocol including a medial parapatellar approach, without tourniquets. During surgery, five to eight tantalum 1 mm beads (RSA Biomedical, Sweden) were inserted in tibial bone with a fair geometrical spread.
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3

Minimally Invasive Knee Arthroplasty

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All patients were operated on under spinal anesthesia in a supine position, by a single, non-designer surgeon experienced in knee and hip arthroplasty. No tourniquet was used. A standard mini-medial parapatellar approach was used for all patients. A routine inspection of the patellofemoral and lateral compartments was conducted. The integrity of the cruciate ligament was evaluated. The medial and intercondylar osteophytes were removed. An anterior tibial pre-cut was performed to allow articular exposure. The PPK system (Zimmer, Warsaw, Indiana, USA) was implanted using the corresponding instrumentation, extramedullary tibial guide, and the femoral and tibial cutting guides by following manufacturer instructions [22 ]. All the components were cemented using Refobacin® Bone Cement R (Zimmer-Biomet, Warsaw, Indiana, USA). One closed suction subcutaneous drain was used and removed on the first postoperative day. The postoperative rehabilitation protocol was identical for all patients and followed published guidelines [23 (link)].
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4

Standardized Unilateral Knee Arthroplasty

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Surgery was performed by one author with long experience in UKA in a highly standardised fashion. The implants were fixed-bearing medial PPK (Zimmer Biomet, Warsaw, Indiana, USA) and fixed-bearing lateral ZUK (Lima Corporate, Udine, Italy). All patients were placed in a supine position on a standard operating table under spinal anaesthesia. A standard medial or lateral parapatellar approach was used. Inspection of the patellofemoral and medial compartments was performed. All components were cemented using Refobacin Bone Cement R (Zimmer Biomet, Warsaw, Indiana, USA). An intraarticular drain was placed and removed on the first postoperative day. Enoxaparin sodium 4000 units subcutaneously daily for 45 days was used as thromboembolic prophylaxis.
The postoperative protocol was conducted following a previous report [36 (link)]. Briefly, both the patient groups followed the same rehabilitation protocol involving passive mobilisation from day one after the surgery. From day two, they started an active progressive mobilisation of the joint and assisted walking with two crutches. According to each patient’s capability, a gradual increase in the load during walking was recommended, continuing with isometric muscle toning exercises until the total abandonment of walking aids.
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5

Uncemented vs. Cemented Medial UKA

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The prostheses were phase 3-alpha Oxford medial UKA with ArCom ultra-high molecular weight polyethylene-bearings and twin-pegged femoral components (Zimmer Biomet, Warsaw, IN, USA). In the cemented group, both the tibial and femoral components were fixed with Refobacin Bone Cement R (Zimmer Biomet, Warsaw, IN, USA). In the cementless group, the tibial and femoral components were coated with plasma-sprayed 750-µm-thick titanium and an additional coating of plasma-sprayed 55-µm-thick hydroxyapatite and inserted press-fit.
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6

Cemented Femoral Component Implantation

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We prepared 18 bone analogues (Sawbones medium left femur model 3403; Pacific Research Laboratories, USA) for cemented implantation of the femoral components. These were divided into three groups of six each. We used The Optipac system (Zimmer Biomet, USA), which is already pre-packed with an identical amount and type of bone cement. The system contained 80 g of Refobacin Bone Cement R (Zimmer Biomet), which was stored at ambient temperature, for filling in the Palamix and EasyMix systems.
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7

Cemented Femoral Implant Fixation

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All implant constructs were prepared by an experienced orthopaedic surgeon (YT). According to the plan, we composed a plastic neck cutting guide, and the neck cut was performed accordingly. The bone analogues were broached using the appropriate broaching rasp for each stem. A bone plug made of wax was fixed into the femoral canal distal to the tip of the implant. The implant was then cemented without the use of a stem centralizer into the Sawbone using 80 g of Refobacin Bone Cement R (Zimmer Biomet).
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8

Reverse Shoulder Arthroplasty for Proximal Humerus Fractures

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The greater and the lesser tuberosity fragments were mobilized and grasped with MaxBraid sutures #5 (ZimmerBiomet, Warsaw, IN, USA) sutures. The supraspinatus tendon was released from the greater tuberosity leaving the infraspinatus tendon alone on the greater tuberosity. The fracture stem assembled with the reverse humeral base plate carrying a 10mm polyethylene inlay (Anatomical Shoulder Reverse Fracture, Zimmer Biomet®, Warsaw, IN, USA) was cemented (Refobacin Bone cement R, Zimmer Biomet®, IN, USA) in 20° of retroversion into the humeral shaft. The height of the prosthetic stem was determined by using the upper border of the pectoralis major tendon insertion as a reference.12 (link)
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9

Posterior-Stabilized vs Cruciate-Retaining Knee Replacement

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All patients underwent weight-bearing knee radiographies and magnetic resonance imaging (MRI) preoperatively. Patients were allocated to receive PS or CR implants. The allocation followed the anatomopathological features of the PCL based on imaging, clinical, and intra-operative findings. If the PCL was intact and effective, a CR was implanted; in case of lack of or deficient PCL, a PS was implanted. A standard medial para-patellar approach was used in all patients. No tourniquet was used. All patients received a cemented Vanguard® Knee System (Zimmer Biomet, Warsaw, IN, USA) following manufacturer instructions. Both tibial and femoral components were cemented using Refobacin® Bone Cement R (Zimmer Biomet, Warsaw, IN, USA). No augmentation or stem extension was used. No patellar resurfacing was performed. One closed suction subcutaneous drain was used and removed on the first postoperative day. The postoperative rehabilitation protocol was identical for both groups and followed published guidelines [16 (link)].
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