Implants trauma PROlock Radius Locking Plate 2.0

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 Advanced Properties P. 9 Drill Block P. 10 Indications & Contraindications P. 10 Time of operation 2. Surgical Technique P. 12 Pre-operative patient preparation P. 13 Access P. 13 Implantation P. 21 Postoperative treatment P. 21 Explantation P. 21 Summary 3. Information P. 23 Locking P. 23 Dotize® P. 24 Order list P. 26 Reconditioning Manual

Preface The development of the PROlock Radius Locking Plate 2.0 is based on the excellent results of the previous ITS. Radius Plates. Minimization of flexor tendon irritation due to the anatomical plate design and rounded edges. Precise and rapid screw placement of the distal plate holes with predefined angles using the radiolucent drill guide. 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).

Spiral Drill, D=2.0mm, L=100mm, AO Connector Cortical Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.4mm, L=100mm, AO Connector Cancellous Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.0mm, L=100mm, AO Connector Spiral Drill, D=1.8mm, L=100mm, AO Connector Guide Wire, Steel, D=1.6mm, L=150mm, TR, w. thread

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 • Left/right version • Minimization of flexor tendon irritation due to anatomical plate design • K-Wire holes for preliminary plate fixation • Oblong hole for optimal positioning and adjustment of radius length • Plate lenghts: 3, 5-hole • Optional wide version: 3, 5-hole • Optional narrow version:...

♦ Predefined angles of the distal holes Version left Version right Hole number Direction proximal/distal Direction ulnar/radial

Drill Block Properties: • Precise and rapid screw placement with predefined angles • Click mechanism for easy mounting and dismounting • Radiolucent • Allows for screw insertion through drill block • Color coding for left and right version Assembling: • Slide the drill block to the distal end till it audible engages into the designated holes (see picture on the right, red marked) • In addition, there is the possibility to fix the drill block with a K-Wire (see picture on the right, blue marked) Identification of screw length: • PROlock II in single-hand design depth gauge (59026) can be pushed...

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: • Very advanced osteoporosis with soft bones • Disintegration of the radius-joint surfaces to the extent that there is no support for screws • Obesity • Lack of patient compliance Time of operation: • Acute, on the day of the accident • After swelling has subsided (5-10 days) • In the case of additional questions concerning the wrist surface, a CT scan can be performed.

Surgical Technique

Pre-operative patient preparation • 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 The skin incision is performed on the distal forearm volar, above the tendon of the flexor carpi radialis and reaching to the crease of the wrist (FCR-approach). Split the deep fascia of the forearm. Release the pronator quadratus muscle from the distal radius beginning at the radial edge. Implantation Suspending the thumb with a counterpoise, the fracture is loosened and the length restored. The individual fragments are reduced with the appropriate instrumentation, and, if necessary, the comminuted zones are filled with bone substitute to achieve a provisional reduction in position and...

Possible temporary fixation of individual fragments using a guide wire, steel, D=1.6mm, L=150mm, TR w. Thrd. (35164-150) - check reduction under fluoroscopy. After anatomical reduction is achieved, the implant is chosen and, if required, its contour can be modified. First, fill the oblong hole with a D=2.7mm cortical screw (32271-XX) (suitable drills see page 6). Check the reduction and position of the plate under fluoroscopy.

Due to the oblong hole it is possible to adjust the plate position either distal or proximal.

For temporary fixation of the fragments there are 3 distal K-wire holes.

Next fill the shaft holes with either D=3.0mm cortical stabilization screws (37304-XX) or with D=2.7mm cortical screws (32271-XX) (suitable drills see page 6).

After re-checking the reduction 4 or more D=2.4mm stabilization screws (37241-XX) or D=3.0mm cancellous stabilization screws (37303-XX) should be used for the relevant fragments (suitable drills see page 6). Pay attention that the distal locking screws are placed as closely to the wrist surface as possible in order to take advantage of the hard subchondral bone. Two rows of screws are recommended to provide optimal support to the articular surface especially if only the D=2.4mm stabilization screw is used. Final check under fluoroscopy.