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i. Implants ii. Systems 1. Surgical material 2. Surgical approach I 3. Application I 4. Surgical approach II 5. Application II 6. Osteotomy 7. Finishing RatNail Surgical technique guide

RatNail SGT

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The RatNail system is a locked intramedullary nail made of medical grade stainless steel 1.4441 (316L). The implant is available in two standard sizes (depending on femural length) allowing for osteotomies from 0.25 to 6.00 mm. The pin driver for insertion of the locking pins is an integral component of the pin design and shears off once sufficient torque is applied. The locking pin is designed to extend over the opposite cortex and makes unlocking for implant removal possible. For practical application of the RatNail an aiming device with various saw guide clips is available.

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Page 1: RatNail SGT

i. Implantsii. Systems1. Surgical material2. Surgical approach I3. Application I4. Surgical approach II5. Application II6. Osteotomy 7. Finishing

RatNailSurgical technique guide

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Intramedullary fixationStabilization of a single cut / large gap osteotomy with a locked intramedullary nail. Possible osteotomy sizes from 0.25 to 6.00 mm. A fracture model is also possible.

i. ImplantsTechnology The RatNail system is a locked intramedul-lary nail made of medical grade stainless steel 1.4441 (316L). The implant is available in two standard sizes (depending on femural length) allowing for osteotomies from 0.25 to 6.00 mm. The pin driver for insertion of the locking pins is an integral component of the pin design and shears off once sufficient torque is applied. The locking pin is designed to extend over the opposite cortex and makes unlocking for implant removal possible.

For practical application of the RatNail an aiming device with various saw guide clips is available.

i

RatNail

RatNail locking pin

RatNail

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The RatNail system can cover single cut osteotomies up to large bone defects within the femur.

ii. Systems

RatNail with 0.25 mm osteotomy

RatNail with 6.00 mm osteotomy

RatNail

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Implants:- 1x RatNail - 2x RatNail locking pins

1. Surgical material

Implant specific instruments:- 1x RatNail aiming device- 1x Saw guide 0.44 mm

Instruments:- 2x hand drills - 1x Accu Pen 6V+

Consumables:- 1x 0.71 mm Drill bit- 1x 0.44 mm Gigly wire saw, 0.50 m- 1x 1.00 mm Centering Bit- 1x 21 G needle, length > 45 mm- 1x Vicryl suture 3-0 - 1x Polyamid suture 3-0- 1x Reamer 1.65 x 30.50 mm- 1x Drill Bit 2.00 mm

RIS.222.210 RatNail XL

RIS.222.211 RatNail locking pin XL

RIS.322.110 RatNail aiming device XL RIS.322.210 RatNail Sawguide, 0.50 mm XL

RIS.390.211 Accu Pen 6V+RIS.390.130 HandDrill

RIS.592.206 Drill Bit 0.71 mm

RIS.590.112 Square box wrench 0.70 mm

RIS.590.110 Gigly wire saw 0.44 mm

RIS.592.205 Centering Bit 1.00 mm

RIS.522.100 Reamer 1.65 x 30.50 mm

RIS.592.209 Drill Bit 2.00 mm

RatNail

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Positioning Rat in dorsal position.

2. Surgical approach I

RatNail

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PositioningThe knee is bent according to illustration.

2. Surgical approach I

RatNail

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Anterior approachLongitudinal skin incision over the knee from the distal third of the thigh to the proximal third of the lower leg.

2. Surgical approach I

RatNail

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Longitudinal incision along the medial side of the patellar tendon.

2. Surgical approach I

RatNail

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Lateral dislocation of the patella to expose the knee joint.

2. Surgical approach I

RatNail

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Position of the intercondylary entry point on the femur.

2. Surgical approach I

X

RatNail

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Opening of the epicondyle

Use the 2.00 mm drill bit to drill a hole into the intercondylar notch. According to the illustration start drilling with a 45 ° offset to the axis of the femur and continuously decrease the angle to 0° offset (parallel with the bone axis). Make sure not to exceed 4.00 mm in depth for the drill hole !

Verify the orientation of the longitudinal axis and keep the drill bit right between the two condyles of the medullary cavity and parallel to the bone axis.

3. Application I

RatNail

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Proximal opening of femurUse the 1.65 mm reamer to ream the medullary cavity. Again make sure that the orientation is central to the medullary cavity and parallel to the bone axis ! Open the femur proximally with a 21G needle > 45 mm, to prepare the insertion of the threaded tip of the RatNail.

3. Application I

RatNail

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3. Application IInsertionInsert the RatNail under continous rotation until the notch at the distal end of the RatNail is flush with the epycondyle.Make sure to apply smooth axial pressure during insertion.

RatNail

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RatNail in situ.

3. Application I

RatNail

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Positioning

Rat in prone position.

4. Surgical approach II

RatNail

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Anterolateral approachLongitudinal skin incision along the femur from the hip joint to the knee.

4. Surgical approach II

RatNail

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Small medial incision of the fascia lata and blunt preparation of the muscle below.

M. vastus lateralis and M. biceps femoris are split and M. tensor fasciae latae is lifted to expose the full length of the femur preserv-ing the sciatic nerve.

Circular preparation of the femur at the area of the planed osteotomy.

4. Surgical approach II

RatNail

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AssemblyMount the aiming device to the RatNail.

Pay special attention to the final position of the aiming device. Make sure there is no gap between the RatNail adapter flanch and the inner surface of the aiming device (marked in red).

Orientation of the aiming devicePosition the aiming device anterolaterally to the femur.

5. Application II

RatNail

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Interlocking of the RatNailStarting with the more proximal interlocking position use the 1.00 mm centering bit to prepare for drilling. Maintain the orienta-tion of the aiming device and drill the first interlocking hole with the 0.71 mm bit. The countersinking as well as the drilling should be done by hand without the use of power tools ! Carefully apply the RatNail locking pin via the aiming device and bring it into its final position by turning it into the RatNail under continuos axial load. The locking pin drive shaft shears of as soon as the interlocking torque is achieved. Repeat this for the remaining interlocking position. Two locking pins are sufficient.

5. Application II

1. countersinking 2. drilling 3. interlocking

RatNail

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6. OsteotomyPerforming the osteotomyAttach the 0.44 mm saw guide on the lateral side of the aiming device and create a de-fined gap by using the Gigly saw (sufficient irrigation !) Start sawing by keeping your hands close to-gether. With progressing saw depth increase hand distance to avoid high forces.To ensure circular cutting of the bone repeat the sawing procedure on both sides of the aiming device.

RatNail

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6. OsteotomyAccomplishing the osteotomyDisconnect the shaft of the RatNail at the groove (marked red) by bending the aiming device carefully to the side while holding the leg.

RatNail

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7. FinishingWound closureLift the M. quadriceps gently over the femur to its original position. Use vicryl suture 3-0 to close the fascia lata and polyamid suture 3-0 for the skin.

RatNail

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Wound closureTo reconstruct the medial ligament use vicryl suture 4-0 on the patellar tendon and the fascia lata.

7. Finishing

RatNail

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7. FinishingWound closure Skin suture with polyamid suture 3-0.

RatNail

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Hazards and legal restrictionsScientific editor: Katharina Schmidt-Bleek, Germany Agnes Ellinghaus, GermanyIllustrations: Sandra Wissing, SwitzerlandDesign and layout: Romano Matthys, Switzerland In collaboration with: Julius Wolff Institut and Center for Musculoskeletal Surgery Charité-Universitätsmedizin Berlin, GermanyHazards Great care has been taken to maintain the accuracy of the information contained in this publication. However, the publisher, and/or the distributor, and/or the editors, and/or the authors cannot be held responsible for errors or any consequences arising from the use of the information contained in this publication. Contributions published under the name of individual authors are state-ments and opinions solely of said authors and not of the publisher, and/or the distribu-tor, and/or the RISystem Group. The products, procedures, and therapies described in this work are hazardous and are therefore only to be applied by certified and traine medical professionals in environments specially designed for such procedures.

RISystem AGTalstrasse 2A7270 [email protected]

No suggested test or procedure should be carried out unless, in the user‘s professional judgment, its risk is justified. Whoever applies products, procedures, and therapies shown or described in this work will do this at their own risk. Because of rapid advances in the medical sciences, RISystem recommends that independent verification of diagnosis, therapies, drugs, dosages, and operation methods should be made before any action is taken. Although all advertising material which may be inserted into the work is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement by the publisher regarding quality or value of such product or of the claims made of it by its manufacturer.

RatNail