Implants trauma PROlock Radius 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. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent...

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 Preoperative P. 10 Access P. 10 Reduction P. 11 Implantation P. 12 Fixation of the distal fracture fragments P. 12 Postoperative treatment P. 13 Explantation P. 13 Summary P. 13 Case study 3. Information P. 15 Locking P. 15 Dotize® P. 16 Order list P. 18 Reconditioning Manual

Preface Minimization of flexor tendon irritation due to anatomical plate design and rounded edges of the PROlock Radius Locking Plate. The special feature of this implant is the free choice of screw placement. The user is able to set any desired screw in any hole (except oblong hole). The free choice of screw angulation (+/- 15°, see page 15) provides an advantage in fracture treatment, especially in the case of complex fractures.

61203-100 Spiral Drill, D=2.0mm, L=l00mm, AO Connector 56095-70-2 Self-holding sleeve, Screwdriver, Torque 9 37302-xx Cancellous Screw, Locking, D=3.0mm 61203-100 Spiral Drill, D=2.0mm, L=l00mm, AO Connector 56095-70-2 Self-holding sleeve, Screwdriver, Torque 9 35164-150 Guide Wire, Steel, D=l.6mm, L=l50mm, TR, w. Thrd.

Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy Multi-directional Locking Anatomical plate design Design for left and right External contour adapted to the distal radius • Design: wide (5 distal holes), narrow (4 distal holes), long (6 shaft holes), short (4 shaft holes) • Optional long plates (8, 10, 12-hole)

Indications, Contraindications & Time of operation Indications: • Complex intra- & extra-articular fractures of the distal radius with comminuted zone • Corrective osteotomy of the distal radius Contraindications: • Disintegration of the radius-joint surfaces to the extent that there is no support for screws • Existing infections in the fracture zone and operation area • Common situations that do not allow osteosynthesis • Obesity • Lack of patient compliance Time of operation: • Acut, on the day of the accident • After swelling has subsided (5-10 days)

Surgical Technique

Preoperative • An X-ray of the healthy wrist (opposite side) is obligatory to serve as a comparsion • The patient is placed in the supine position with pneumatic partial deprivation of blood supply • The hand is positioned on a radiolucent surgical hand table Access Approach over the tendon of the flexor carpi radialis muscle: • The skin incision is performed volarly on the distal forearm above the tendon of the flexor carpi radialis and reaching to the crease of the wrist (FCR-approach). • Splitting of the deep fascia of the forearm, releasing the pronator quadratus muscle from the distal radius...

Implantation • Possible temporary fixation of individual fragments using K-Wires. Check reduction using the fluoroscope. • After anatomical reduction is achieved, the implant is chosen and, if required, its shape can be additionaly adapted. • First, occupy the sliding hole with a Cortical Screw (it is also possible to fasten the plate on the bone using the PROlock Fixation Wires). Then check the reduction and position of the plate using the fluoroscope. • It should be paid attention that the distal locking screws should be attached as closely to the wrist surface as possible in order to take...

Fixation of the distal fracture fragments • The locking D=3.0mm cancellous screws should only be used in the two distal hole series, and the cortical screws should only be used in the shaft holes. Postoperative treatment • Dorsal splint (1-2 weeks) • Physical therapy

Explantation If desired by the patient, the implant can be removed. Removal should be performed at the earliest 6 months later or after radiographic verification of the healed bone. The problem of cold welding was resolved by using a special surface treatment (for further information see page 15). Summary The locking Radius Plate of I.T.S. has proved itself in extension fractures of the distal radius with dorsal comminution zone. Using this technology, an anatomic reduction was achieved and maintained until healing occurred. Due to the low immobilisation time of 2 weeks, rapid rehabilitation...

Locking Locking works because: • 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 Radius Plate PROlock, Small, 4-hole, Left Radius Plate PROlock, Small, 4-hole, Right Radius Plate PROlock, Small, 6-hole, Left Radius Plate PROlock, Small, 6-hole, Right Radius Plate PROlock, Wide, 4-hole, Left Radius Plate PROlock, Wide, 4-hole, Right Radius Plate PROlock, Wide, 6-hole, Left Radius Plate PROlock, Wide, 6-hole, Right Special lengths (on request) Radius Plate PROlock, Small, 8-hole, Left Radius Plate PROlock, Small, 8-hole, Right Radius Plate PROlock, Small, 10-hole, Left Radius Plate PROlock, Small, 10-hole, Right Radius Plate PROlock, Small, 12-hole, Left Radius Plate...