AQ Implants REVISIO RTM Gebrauchsanweisung Seite 11

replacement of the knee joint.
5.3 Indications REVISIO RTM Endofemoral Module
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The intramedullary total femur is indicated in cases where load-stable reconstruction of the fe-
mur can be achieved with or without partial resection and existing tendon and muscle insertions
as well as the patellar bearing can be preserved.
• Loss of the weight-bearing function of bones and adjacent joints
• Degenerative joint diseases (e.g. avascular necrosis, osteoarthritis, rheumatoid arthritis,
requiring extended resection and reconstruction of the hip and/or knee joint).
• Significant bone loss and/or severe ligament instability.
• Correction of functional varus and valgus deformities
• Metastatic diseases (e.g. giant cell carcinoma, osteosarcoma, chondrosarcoma, bone
tumours requiring extended resection and reconstruction of the proximal and/or diaphyseal
femur and/or proximal tibia).
• Multiple revision arthroplasties of the knee and/or hip joint requiring reconstruction of the
proximal, diaphyseal and/or distal femurs and/or proximal tibia.
• Traumatic injuries requiring extended replacement of the proximal, distal, diaphyseal or total
femur and/or proximal tibia.
• Periprosthetic fractures
• Intraprosthetic fractures
• According to the indication for the REVISIO
and muscle insertions as well as the patellar bearing might be preserved.
Note:
Indication for cementless procedures requires sufficient bone quality. Especially in patients with
cement incompatibility, cementless fixation provides a viable alternative. If cementless fixation is
contraindicated, the prosthesis must be cemented.
6. Contraindications
6.1 General contraindications
• Acute or chronic, local or systemic, uncontrollable infection
• Insufficient bone quality or conditions jeopardising a stable fixation of the prosthesis
• Vascular, muscular, or neurological diseases compromising the affected area
• Any comorbidity that might affect bone regeneration or implant function (e.g. severe
metabolic disorders)
• High physical strain (e.g. competitive sports, hard physical work)
• Incomplete skeletal growth
RTM systems, whereas existing tendon
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• Allergies to implant materials
• Morbid obesity or high weight gain
• Pregnancy and breastfeeding
• Lack of compliance
• Intake of high doses of cortisone or cytostatic drugs
• High tendency of falling or other circumstances that might lead to an increased fracture risk
• Cement intolerance in cemented prostheses
Contraindications comprise any circumstances making surgery inadvisable or impossible, such
as coagulation disorders (also caused by indispensable anticoagulants), non-treatable high blood
pressure, new myocardial infarction, cardio-vascular diseases, severe cardiac insufficiency, ana-
esthetic intolerance, or poor general condition of the patient.
Mental and neurological conditions present a contraindication in case of the patient's lack of
willingness or ability to restrict movement.
There is no adequate research on the use during pregnancy and breastfeeding. Therefore, the
implant should not be used in pregnant and nursing women.
6.2 Specific contraindications
a) REVISIO RTM System
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• Contraindications regarding metastatic diseases:
• Any concomitant condition that might lead to a local or non-local spread of tumours
• Pathological bone fractures
• Open infections
• Excessively fast progression of the disease
b) Endofemoral Replacement
• Acute purulent bone or soft tissue inflammations
• Cement ageing and specific antibiotics in the cement mixture
7. Potential adverse effects
The expected life expectancy of an implant can be impaired in young, very tall and obese pa-
tients and patients who are physically very active. Wrong selection or maladjustment of the