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AQ Implants REVISIO RTM Gebrauchsanweisung Seite 10

Revisions- und tumorsystem
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In order to achieve optimal primary fixation as a prerequisite for long-term stability of the pros-
thesis, the following points should be observed:
Preservation of adequate bone structure / wall thickness during the preparation of the host bone
Selection of the appropriate implant size
Adequate cleaning of the host bone prior to implantation
Application of moderate force during implantation to avoid bone fissures or implant damage.
Compatibility of the individual components
Observance of surgical technique, user notes, and warnings
Clean and dry surfaces of tapered connections
Firm coupling of tapers achieved by using insertion and impaction instruments
Avoid damage to the components
Avoid foreign particles, such as bone or tissue debris or cement particles between functional
surfaces (e.g. tapers, holes, articular surfaces)
Use of locking screws in screw-retained components (e.g. fixation of the iliac peg)
In addition, the following points should be observed for cemented All-Poly Cups:
Observance of the processing specifications for bone cement (PMMA), mixing ratio as well
as polymerisation temperature and time in accordance with the manufacturer's instructions
Appropriate mixing of polymer and monomer
Application of bone cement of appropriate viscosity without blood and air inclusion
Uniform cement mantle around the implant
Appropriate press-fit and resting of the implant during polymerisation
Thorough removal of excessive bone cement from bony edges
Thorough rinsing of the surgical site prior to reposition and wound closure to avoid cement
particles and bone fragments from getting trapped between joint surfaces or functional and
clamping surfaces, holes, etc.
Caution:
The cement mantle should fully enclose the implant in the fixation area. An incomplete cement
mantle can lead to early loosening of the implant.
Note:
Bearing surfaces and tapers of the prostheses can be damaged by surgical instruments or bone
cement particles. In order to guarantee the safe and reliable function, they have to remain intact.
Therefore, these areas should be covered with surgical drapes during implantation.
Note:
The tapers of the prostheses can be damaged by surgical instruments or bone cement particles.
In order to guarantee the safe and reliable function, they have to remain intact. Therefore, these
areas should be covered with the supplied taper covers and surgical drapes during implantation.
Bearing surfaces of the prostheses can be damaged by surgical instruments or bone cement par-
ticles. In order to guarantee the safe and reliable function, they have to remain intact. Therefore,
these areas should be covered with surgical drapes during implantation.
5. Indications
Implantation of a prosthesis should be taken into consideration, if conservative measures or
other surgical measures prove not to be appropriate. Even successfully implanted prostheses
are inferior to the natural joint. Implant loosening, wear, and implant failure may necessitate
revision surgery.
5.1 Indications REVISIO
®
RTM System
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.
In cases where alternative, less invasive methods do not seem to be promising
5.2 Specific indications REVISIO
RTM System
®
Proximal femur replacement: large bone defects (tumours) in the proximal femur
Diaphyseal replacement: Bone defects (tumours) in the diaphyseal femur
Distal femur replacement: Bone defects (tumours) in the distal femur with partial
replacement of the knee joint preserving the proximal tibia
Distal femur replacement and proximal tibia replacement: Bone defects (tumours) in the
distal femur and proximal tibia with total replacement of the knee joint.
Total femur replacement: Bone defects (tumours) in the femur and tibial head with total
loading