Affinis Fracture ceramic head is a component of an implant used in shoulder replacement surgeries. It replaces the humeral head in the. Mathys Orthopaedics, in association with the Therapeutic Goods Administration of Australia, has issued a hazard alert for the Affinis Fracture. ence with the Articula prosthesis, the next generation, Affinis Frac- ture, has now been With the Affinis Fracture, we are now taking the next step, and.

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Introduction Introduction New features Proven advantages Implant philosophy 5 2. Indications Indications Contraindications 6 3. Pre-operative planning 7 4. Instructions for surgery Positioning Surgical technique 8 5. Overview of implants Overview of instruments 17 Note Please make yourself familiar with the handling of the instruments, the product-related surgical technique and the warnings, the safety notes as fracutre as the recommendations of the instruction leaflet before using an implant manufactured by Mathys Ltd Bettlach.

Make use of the Mathys user training and proceed according to the recommended surgical technique. Based on many years of very positive experience fractire the Articula prosthesis, the next generation, Affinis Fracture, has now been developed.

The aim of fracture prosthesis is to restore mobility and to eliminate pain, so that the patient can manage the activities of everyday life. A main objective here is the anatomical reconstruction of the rotator cuff, affiinis is achieved through the precise and secure fixation of the tuberosities to the shaft of the humerus and the prosthesis.

You can continue to rely on the existing benefits such as continuously variable adjustment of height and retroversion, as well as primary stability affinks by the spikes. Based on CT-models the prosthesis has been anatomically redesigned.

Avfinis the latest findings in refixation techniques have been incorporated. On growth of the tuberosities is furthermore improved by the newly added bioactive CaP coating.

The result will please you too: Stable reattachment of the tuberosities plays just as important a role here as the anatomical shaping of the metaphysial prosthesis component central part which supports ongrowth behaviour.

For this reason, the central part of the Affinis Fracture has been provided with a arfinis surface as well as a bioactive coating. Blood cells which stimulate bone growth are attracted through the porous surface structure.

Affinis Fracture Trauma Shoulder Prosthesis. Surgical technique – PDF

These cells activate the surrounding bone. Through this, the calcium phosphate is converted into endogenous bone within a short space of time approx. This leads to greatly improved adhesion of the tuberosities. These tracture ensure a high degree of primary stability as well as greater secondary stability, which is achieved through improved osteointegration of the tuberosities.

To avoid allergic reactions, ceramic components are offered Immaturity of the skeleton 6. Pre-operative planning 30 Transparent templates of the implants are available in the usual scale of 1. The following X-rays of the affected shoulder are recommended: Instructions for surgery 4. Make sure that the medial border of the scapula is still supported by the table.

The arm is wrapped in a sterile manner and can be laid on an arm rail but must remain freely movable The shoulder joint should remain accessible from all sides, including function testing and X-ray checks with the image converter The trunk component of the table should be raised by about 35 Angle the lower leg component Position and secure the head in the head support 4.

If necessary, the skin incision can be extended to the lateral third of the clavicle as indicated by the broken line. Other approaches are possible at the surgeons discretion. This vein is usually retracted laterally, together with the deltoid muscle. After mobilisation of the coraco-brachial tendon group in a medial direction, the musculo-cutaneous nerve is palpated posteromedial to the tendons.

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The nerve should be held to the side with the tendons. In this case, please mark the highest point of its insertion beforehand. This will allow you to use the insertion as a reference point later.

The long biceps tendon serves as a guide for identifying the lesser and greater tuberosity. The incision over the tendon proceeds in a proximal direction as far as the coraco-acromial ligament, which can be partially notched in contracted situations. The rotator cuff is then split in line with the fracture up to the base of the coracoid process. If not possible, the interval between the subscapularis and the supraspinatus should be split. The intra-articular stump is resected.

After that, the axillary nerve is palpated at the front and underside of the subscapularis. If the fracture extends into the shaft, the nerve must be exposed and held away. Identification can be difficult in the case of older fractures and adhesions. The axillary nerve must be protected throughout the entire operation.

It is important here to protect the periosteum on the proximal shaft. If a fracture has resulted in an isolated greater tuberosity fragment and a lesser tuberosity fragment, these are reinforced with holding sutures. The mostly flat but compact calotte fragment is often tipped in a dorsal or medial direction. It must be extracted carefully, and used for obtaining cancellous bone.

The glenoid is now assessed, and can likewise be replaced if necessary. The implantation of a glenoid component is described in the surgical technique for the Affinis total shoulder prosthesis.

There is often a connection between the calotte and the dorsal parts of the greater tuberosity, which aaffinis osteotomised close to the head fragment, leaving the tuberosity and rotator cuff fragments. Often, the tuberosities themselves are also fragmented. In this case, the smaller partial fragments should also be securely reinforced. Coagulations and any fraccture splinters are carefully removed from the intramedullary canal.

The medullary space is now drilled step by step using the medullary reamer, until the desired stem size is reached. The stem size always corresponds to the numbering of the medullary reamer: Medullary reamer D in mm Stem size Fig. These should be inserted medially and laterally of the sulcus, before the prosthesis stem is cemented in. This means that after cementing, it is still possible to displace the central part of the prosthesis 5 mm caudally affjnis cranially respectively, for fracturr purposes of exact anatomical positioning.

The adjusting screw is used to fix the central part and stem temporarily. The use of a medullary plug is recommended. The central part is placed on the medial calcar, which usually remains static and is very suitable as a starting point for height adjustment. Calcar remnants on the humeral head have to be included in the calculation for the correct length adjustment.

If there is an extreme comminution of the medial metaphysis, the anatomical repositioning using the medial calcar can become impossible. A further possibility for fracturd the correct height is then provided by the fractuee method after Murachovsky et al JSES15,: Here, the height from the upper edge of the pectoralis major muscle attachment on the shaft of the humerus to the upper edge of the prosthesis head is measured.

According to the anatomical study, this is 56 mm on average. Fracturw simplification, the distance from the pectoralis major to the shoulder of the central part can be measured, with the adjustment value here being 43 mm. The alignment towards the lower arm corresponds to a retroversion of 30 to the lower arm and 20 to the transepicondylar axis. Bone cement must be removed, so as not to hinder adjustment of the central part. Any cavities remaining distally can be filled up with chips of cancellous bone.

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After the bone cement has hardened, the trial head is mounted the size depends on the calotte that has been removed.

In order to avoid overstuffing, in cases of doubt the smaller head should be used. The fine adjustment of height and retroversion is now carried out in accordance with the anatomical circumstances, with the aim of achieving an optimum ligament tension, as well as centring of the prosthesis to the glenoid.

For this, in a neutral position, the central part adjusting screw is aligned to the lower arm. Alternatively, the retrotorsion pointer can also be used. With both methods, a retrotorsion of 30 to the lower arm or accordingly 20 to the transepicondylar axis is ensured.

The adjusting screw should be tightened as soon as the optimum setting has been achieved.

The central part must completely cover the slits on the stem bracing mechanism. Checking is performed laterally through the placement of the greater tuberosity. The upper edge of the greater tuberosity should come to rest 5 8 mm below the calotte height, and as far as possible it should lie edge to edge on the lateral shaft. The acromio-humeral distance should be approx. After the desired position has been achieved, the adjusting screw is tightened and the following parameters are checked by moving the arm whilst monitoring with an image converter: The distance between the greater tuberosity and the head 5 8 mm The degree of retroversion centring to the glenoid The size of the head The prosthesis height subacromial space, ligamentous tension.

Pre-fixation of the central part with the Allen key, until a resistance is encountered. The counter wrench is mounted, to secure the central part against rotation, and the torque wrench is inserted. The use of the counter wrench is mandatory. Tensioning takes place by turning the torque wrench clockwise.

Affinis Fracture Trauma Shoulder Prosthesis. Surgical technique

When the indicator of the torque wrench points next to the wrench handle, permanent bracing has been achieved. The adjusting screw can now be removed. The definitive prosthesis head corresponding to the size of the trial head is then fixed through firm mounting and slight turning. This ensures the anatomical transition of the supraspinatus to the prosthesis head.

Where possible, the lesser tuberosity should be included in this fixation.

The positioning and fixation of the two tuberosities is now carried out in anatomical position relative to one another and to the shaft green suture. Fixation or compression sutures 3. Using the fracturf placed fractire the shaft at the outset, the tuberosities are now fixed on the shaft of the humerus.

These sutures must be tightened forcefully. The whole package is then compressed onto the bioactively coated central part, by means of encircling suture or cable. A high degree of primary stability is thereby achieved. Secure and anatomically correct fixation of the tuberosity fragments is of greatest importance for the functional outcome of the operation.