Implants trauma Calcaneus Locking Plate

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break.

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Positoning of the patient P. 10 Calcaneus Distractor & Heel Press P. 11 Diagnosis P. 11 Access P. 11 Reduction P. 12 Fixation P. 13 Postoperative treatment P. 13 Explantation 3. Information P. 15 Locking P. 15 Dotize® P. 16 Order list P. 18 Sterilization guidelines

Preface Locking Calcaneus Plate is a tried and tested osteosynthesis system for various calcaneus fractures. The special feature of this implant is the free choice of screw placement. So the user is able to set every desired screw in every hole (either locking or non-locking screw). The free choice of screw angulation (+/- 15°, see page 15) provides an advantage in fracture treatment, especially in the case of complex fractures.

Cancellous Screw, locking, D=3.5mm, SH Spiral Drill, D=2.0mm, L=100mm, AO Connector Screwdriver, WS 2.5, with self-holding sleeve Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, with self-holding sleeve Cancellous Screw, locking, D=4.2mm, SH Spiral Drill, D=2.5mm, L=110mm, AO Connector Screwdriver, WS 2.5, with self-holding sleeve All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate has to be formed to the bone please notice that slight contouring is possible. Attention: Significant bending at the locking holes will reduce locking effectiveness...

Properties Properties of the implant: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of implant after fracture has healed • Improved fatigue strength of implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional locking • Anatomically plate design • Short and long version

Indications, Contraindications & Time of operation Indications: • Complex fractures of the calcaneus • All intra-articular fractures with relevant joint distortion and a comminution zone in which a semi-operative procedure (screws, drill wires) does not raise expectations of exact repositioning Existing infections in the fracture zone and operation area Common situations that do not allow osteosynthesis Obesity Lack of patient compliance Time of operation: • After regression of the swelling (5 to 10 days)

Surgical Technique

Positioning of the patient • Supine position or lateral position • Blood arrest Calcaneus Distractor & Heel Press • Through small incisions, transversally from the lateral, D=3.2mm Kirschner Wires are inserted into the neck of the talus and the tubelar part of the calcaneus. • One of the distracters is inserted on the lateral end of the wires. It should be 20 millimetres far from the epidermis. • The threaded bar of the distractor points towards the proximal on the lateral side of the foot, and the driving disc of the distractor is placed similarly on the medial, but the threaded rod is on the...

Diagnosis Standard X-ray of the calcaneus, axial and coronet CT with reconstructions. Access Expanded lateral approach: • Subperiostal single layered lifting of a lateral skin-soft tissue flap • Hold away the flap by using bent guide wires Reduction • Open reduction under view by mean of Schanz screw, Steinmann nails, guide wires • Padding of comminuted zones with bone replacement

Temporary by guide wires eventual cancellous screws Forming the locking plate for calcaneus Fixation with the cancellous screws in the main fragments Finishing with locking screws

Postoperative treatment • • • • Plastex cast of the lower leg for 2 weeks until healing Physiotherapy Mobilization by crutches Relief of the strain for 8-12 weeks Explantation If desired by the patient, the implant can be removed. Removal should be performed at the earliest 11/2 years later or after radiographic verification of the healed bone. The problem of cold welding was solved by using a special surface treatment (for further information see page 15).

Locking Locking works because of: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Type III anodization Dotize Type II anodization + Film becomes an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration Type - III - No visible cosmetic effect Dotize® Type - II Ti-Oxid Anodization Type II leads...

Order list Calcaneus Plate, Short 21061-51 Calcaneus Plate, Long 21061-60 Cancellous Screw, Locking, D=3.5mm, L=26mm, SH Cancellous Screw, Locking, D=3.5mm, L=28mm, SH Cancellous Screw, Locking, D=3.5mm, L=30mm, SH Cancellous Screw, Locking, D=3.5mm, L=32mm, SH Cancellous Screw, Locking, D=3.5mm, L=34mm, SH Cancellous Screw, Locking, D=3.5mm, L=36mm, SH Cancellous Screw, Locking, D=3.5mm, L=38mm, SH Cancellous Screw, Locking, D=3.5mm, L=40mm, SH Cancellous Screw, Locking, D=3.5mm, L=42mm, SH Cancellous Screw, Locking, D=3.5mm, L=44mm, SH Cancellous Screw, Locking, D=3.5mm, L=46mm, SH Cancellous...

Sterilization guidelines The following remarks should serve as a guideline in the sterilization of medical products. IMPORTANT INDICATIONS FOR DOCTORS AND OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied non-sterile implants and all reusable instruments from ITS GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the packaging label. Make sure that you are familiar with the possible application, combinability and correct handling of the product. Please note...