GENERAL The Rigid Monofixator is designed for orthopaedics and thraumatic surgery and is applied in treatment of long tubular bones. The fixator is the fastest way of stabilizing, using the method of remote osteosynthesis of two fragments - with tightening of just one nut, a reliable fixation is achieved with unlimited number of bone screws.
ADVANTAGES Simple, reliable, light, versatile system. Effective in healing of different types of displaced fractures Very easy to apply within a short operative period. Ensures hopeful fixation in fractures in reduction position. Universal with respect to the choice of implant screws - it allows tightening of screws from 3 mm to 6 mm in diameter. Opportunity to choose freely where to mount the screws: quite near the fracture line and as far from it as possible. Thus long carrying arms can be formed ensuring maximum stability on the axis. Isolator property achieved by hard anodized coating with Al 2 O 3
DESIGN The design of the fixator is compact and has been simplified to the highest degree, allowing quick immobilization of moving bone fragments. The fixator contains of a carrier, shaped as a thin-wall tube (2), containing a body (1) with holes, shaped in it. Bone screws (3) are fixed in (A) and (B) holes by means of a nut (4). Thus remote rapid ostheosynthesis is achieved. The body can move axially in relation to the tube, but it cannot turn around. This is assured by a pin (5) which moves in a groove.
SCREW DESIGN Implant screws are combinations of a drill 1, screw tap 2 and screw 3. That allows screws to be fixed into the bone without preliminary preparation. At the beginning the screw is with an arc profile that slightly turns into cylindrical one. The threading of the screw is with a special self-locking profile that ensures the preservation of maximum osseous tissue. The end of the screw is with a triangular profile that allows fitting to a wrench with the same profile or to a three-jaw chuck. 123
APPLICATION AREA The Rigid Monofixator could be applied in following cases: open and closed fractures in different places; single and multiple fractures; in-joint and out-joint fractures; fractures with infections; unhealed fractures and complex joints (pseudoarthrosis);
OPERATING MANUAL 1. Operation planning 2. Before the operation, concerning the plan, the orthopaedic surgeon chooses the necessary modules from the set and prepares them for sterilisation. 3. Sterilisation is done according to the instructions: Sterilisation approach ImplantsFixatorsInstruments Under pressureYesYesYes TermalYesNoYes With X raysYesYesYes With gasYesYesYes ChemicalYesYesYes 4. Fixators are arranged on a surgical table, in accordance with technology, described in the operation plan. 5. Treat the patient. PREPARING STAGE
OPERATING MANUAL Depending on the position, character and complexity of a particular fracture, the necessary number of screws are inserted in the bones so that they should be against the holes of the fixator. Two of them are placed over and under the fracture line, in the fracture area, the rest are placed as far from the fracture as possible. Guiders and protectors are used for more precise insertion and protection of the soft tissues from additional damage and traumata. The screws should pass through the whole bone, but they shouldn’t penetrate into the opposite soft tissue. After the screws’ insertion, the fixator is strung on the protruding screw stems and the fixator nut is tightened. Thus all the screws are tightened simultaneously and the bone fragments are stabilized. Because of the parallel misalignment of the screws increased solidity of tightening is achieved as a result of the wedging. OPERATING WITH THE SET ‘RIGID MONOFIXATOR’
OPERATING MANUAL OPERATING WITH THE SET ‘RIGID MONOFIXATOR’ screwing a screwstrunging a fixatortightening
OPERATING MANUAL Depending on the volume, size and strength of the broken bones, we propose a method for choosing the appropriate screws based on the following principle: not more than one third of the local bone thickness: BoneScrew diameter [mm] Phalanges of the hands and feet /metacarpal, 2 or 3 metatarsal, heel bones/ Radius and ulna3 or 4 Distal epiphysis of radius and proximal epiphysis of ulna 4 or 5 Distal epiphysis of humerus 4 Diaphyasis and proximal metadiaphyasis of humerus4; 5 or 6 Femur5 or 6 Pelvic bones5 or 6 CHOOSING THE NECESSARY SCREWS
MODULES cat. №Name 803000Module with 9 holes 803000-01Module with 11 holes 803000-02Module with 13 holes 803000-03Module with 15 holes 803000-04Module with 17 holes 803000-05Module with 19 holes SET FOR UPPER EXTREMITY
MODULES cat. №Name 803100Module with 9 holes 803100-01Module with 11 holes 803100-02Module with 13 holes 803100-03Module with 15 holes 803100-04Module with 17 holes 803100-05Module with 19 holes 803100-06Module with 21 holes SET FOR LOWER EXTREMITY
MODULES cat. №Name 803200Module with 4 holes 803200-01Module with 5 holes 803200-02Module with 6 holes 803200-03Module with 7 holes 803200-04Module with 8 holes 803200-05Module with 9 holes 803200-06Module with 10 holes SET OF MINIFIXATORS
SCREWS cat. №Name 700200-02Ø 4 mm L 80/20 700200-03Ø4 mm L 90/20 700200-04Ø4 mm L 100/25 700200-05Ø4 mm L 110/25 700400-01Ø5 mm L 90/30 700400-03Ø5 mm L 100/35 700400-05Ø4 mm L 110/35 700400-07Ø5 mm L 120/40 700400-09Ø5 mm L 130/45 700500-01Ø6 mm L 90/30 700500-03Ø6 mm L 100/35 700500-15Ø6 mm L 110/40 700500-07Ø6 mm L 120/40 700500-09Ø6 mm L 130/40 700500-11Ø6 mm L 140/40 700500-13Ø6 mm L 150/45 700500-15Ø6 mm L 160/50
CANNULATED SCREWS cat. №Name 700600-01Ø6 mm L 90/30 700600-03Ø6 mm L 100/35 700600-05Ø6 mm L 110/40 700600-07Ø6 mm L 120/40 700600-09Ø6 mm L 130/40 700600-11Ø6 mm L 140/40 700600-13Ø6 mm L 150/45 700600-15Ø6 mm L 160/50
KIRSHNER WIRE WITH ROUND END cat. №Name 790100Ø1.5 mm L 70 790100-01Ø2.0 mm L 70 790100-02Ø2.2 mm L 70 790100-03Ø2.2 mm L 70
CLINICAL CASE #1 R.A. 28 year old, d.r. No 1145/28.10.1995 Dg. Osteomielitis femuris hronika fistulosa. Fistula. Chronic thraumatic purulent osteitis of the femur after intramedular osteosynthesis a modo Kuntscher. Engagement of the medular canal and unstable synthesis is seen from the fistulo-graphia. Micrbiologic examination - staphylococcus pureus. Strong necessity of external fixation and removing the nail. The medular canal is strip-drilled and cleaned with antiseptic solutions. Gentamycin pearls (PMMA) are mounted for preparing of the implantation place. After fistulectomia the wound is closed hermetically.
Redon drainage in the canal from the proximal femur. On the 20 th day PMMA are removed and the place is filled with graft from spina ilacia anterior superior, and the donor place is filled with graft from the bone bank /Popkirov/. Redon drainage for 7 days. Smooth postoperative period. Early limb loading. Infection - under control.
CLINICAL CASE #1 Five months later roentgenography shows graft reconstruction. Bone defect recovery. Removed external fixator. Full rehabilitation. Excellent results.