Femur (Femoral) Nail Specification, Uses, Sizes and Surgical Techniques.

Femur Femoral Nail

Femur (Femoral) Nail is designed for varied use. A single nail can be used for both right and left standard interlocking procedures. The Femur (Femoral) Nail is available in the most commonly used sizes. These nails range in diameters from 8 mm to 14 mm and lengths from 240 mm to 420 mm.

Closed intramedullary nailing has long been a common method of treating noncomminuted fractures of the femur. The Femur (Femoral) Nail has extended the indications of closed intramedullary nailing to include comminuted fractures, fractures with bone loss, and proximal and distal fractures of the femur.

The multi-point fixation provided by the cross-section of the Femoral Nail makes it appropriate for use unlocked as well as locked in either the dynamic or static mode. It also makes it appropriate for reamed or unreamed applications. The successful use of Femur (Femoral) Nail is technically demanding. Close attention to positioning, reduction, rod placement, and insertion of the proximal and distal locking screws is mandatory.

Femur (Femoral) Nail Uses

Femur Femoral Nail Uses

Femur (Femoral) Nail is indicated for use in a variety of femoral fractures such as:

  • Comminuted fractures
  • Segmental fractures
  • Fractures with bone loss
  • Proximal and distal fractures
  • Nonunions
  • Subtrochanteric fractures
  • Intertrochanteric fractures

Femur (Femoral) Nail Sizes

Femur (Femoral) Nail diameters are from 9 mm to 14 mm and lengths are from 260 mm to 460 mm

Diameter (mm) x Length (mm) = 9 x 260
Diameter (mm) x Length (mm) = 9 x 280
Diameter (mm) x Length (mm) = 9 x 300
Diameter (mm) x Length (mm) = 9 x 320
Diameter (mm) x Length (mm) = 9 x 340
Diameter (mm) x Length (mm) = 9 x 360
Diameter (mm) x Length (mm) = 9 x 380
Diameter (mm) x Length (mm) = 9 x 400
Diameter (mm) x Length (mm) = 9 x 420
Diameter (mm) x Length (mm) = 9 x 440
Diameter (mm) x Length (mm) = 9 x 460

Diameter (mm) x Length (mm) = 10 x 260
Diameter (mm) x Length (mm) = 10 x 280
Diameter (mm) x Length (mm) = 10 x 300
Diameter (mm) x Length (mm) = 10 x 320
Diameter (mm) x Length (mm) = 10 x 340
Diameter (mm) x Length (mm) = 10 x 360
Diameter (mm) x Length (mm) = 10 x 380
Diameter (mm) x Length (mm) = 10 x 400
Diameter (mm) x Length (mm) = 10 x 420
Diameter (mm) x Length (mm) = 10 x 440
Diameter (mm) x Length (mm) = 10 x 460

Diameter (mm) x Length (mm) = 11 x 260
Diameter (mm) x Length (mm) = 11 x 280
Diameter (mm) x Length (mm) = 11 x 300
Diameter (mm) x Length (mm) = 11 x 320
Diameter (mm) x Length (mm) = 11 x 340
Diameter (mm) x Length (mm) = 11 x 360
Diameter (mm) x Length (mm) = 11 x 380
Diameter (mm) x Length (mm) = 11 x 400
Diameter (mm) x Length (mm) = 11 x 420
Diameter (mm) x Length (mm) = 11 x 440
Diameter (mm) x Length (mm) = 11 x 460

Diameter (mm) x Length (mm) = 12 x 260
Diameter (mm) x Length (mm) = 12 x 280
Diameter (mm) x Length (mm) = 12 x 300
Diameter (mm) x Length (mm) = 12 x 320
Diameter (mm) x Length (mm) = 12 x 340
Diameter (mm) x Length (mm) = 12 x 360
Diameter (mm) x Length (mm) = 12 x 380
Diameter (mm) x Length (mm) = 12 x 400
Diameter (mm) x Length (mm) = 12 x 420
Diameter (mm) x Length (mm) = 12 x 440
Diameter (mm) x Length (mm) = 12 x 460

Diameter (mm) x Length (mm) = 13 x 260
Diameter (mm) x Length (mm) = 13 x 280
Diameter (mm) x Length (mm) = 13 x 300
Diameter (mm) x Length (mm) = 13 x 320
Diameter (mm) x Length (mm) = 13 x 340
Diameter (mm) x Length (mm) = 13 x 360
Diameter (mm) x Length (mm) = 13 x 380
Diameter (mm) x Length (mm) = 13 x 400
Diameter (mm) x Length (mm) = 13 x 420
Diameter (mm) x Length (mm) = 13 x 440
Diameter (mm) x Length (mm) = 13 x 460

Diameter (mm) x Length (mm) = 14 x 260
Diameter (mm) x Length (mm) = 14 x 280
Diameter (mm) x Length (mm) = 14 x 300
Diameter (mm) x Length (mm) = 14 x 320
Diameter (mm) x Length (mm) = 14 x 340
Diameter (mm) x Length (mm) = 14 x 360
Diameter (mm) x Length (mm) = 14 x 380
Diameter (mm) x Length (mm) = 14 x 400
Diameter (mm) x Length (mm) = 14 x 420
Diameter (mm) x Length (mm) = 14 x 440
Diameter (mm) x Length (mm) = 14 x 460

Femur (Femoral) Nail Instruments Set

Femur Nail Instruments Set

Femoral Nail Instruments Set contains instruments required for Femoral Nail which is used for Multi-fragment fractures, Segmental fractures, Proximal or distal non-unions, Proximal or distal mal-unions, Pseudarthrosis, Corrective osteotomies etc.

Femoral Nail Instruments Set Features:

  1. Instruments for Femoral Nails.
  2. Instruments are organised in general order of use.
  3. Femoral Nail Instruments Set can be modified according to customer requirements and preference also, in this case minimum quantities are required.
  4. Instruments are fitted in Silicon Foam.
  5. Graphics of instruments are made in instruments Box to keep Instruments at their define places.

Below are list of items in Femoral Nail Instruments Set.

  • Mechanical Distal Jig for Femur with Handle : 1 Qty
  • Mechanical Distal Jig for Tibia with Handle : 1 Qty
  • Proximal Jig Common for Tibia and Femur : 1 Qty
  • Spanner 17 mm : 1 Qty
  • Nail Holding Bolt : 1 Qty
  • Guide Rod Cannulated : 1 Qty
  • Ram : 1 Qty
  • Driving Head : 1 Qty
  • Holding Forcep for Guide Wire : 1 Qty
  • Drill Sleeve, for 3.2 mm Drill Bit : 1 Qty
  • Protection Sleeve : 1 Qty
  • Trocar : 1 Qty
  • Drill Sleeve for 4 mm Drill Bit : 1 Qty
  • Tissue Protector : 1 Qty
  • Bone Awl : 1 Qty
  • Drill Bit 3.2 mm x 250 mm for Jacobs Chuck : 1 Qty
  • Drill Bit 4 mm x 250 mm for Jacobs Chuck : 1 Qty
  • Screw Driver Hexagonal Extra Long, 3.5mm Tip for 4.9 mm Locking Bolt : 1 Qty
  • Depth Gauge, Measuring upto 110 mm : 1 Qty
  • Medullary Tube : 1 Qty
  • Guide Wire Plain : 1 Qty
  • Guide Wire with Ball Tip : 1 Qty
  • Graphics Aluminium Box with Silicone Fittings : 1 Qty

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Femur (Femoral) Nail Surgical Techniques

The Femur (Femoral) Nail is designed for varied use. A single nail can be used for both right and left standard interlocking or recon procedures. The femoral nail is available in the most commonly used sizes. These nails range in diameters from 9 mmm to 14 mm and lengths from 260 mm to 460 mm.

Preoperative Planning

Proper preoperative planning is essential to successful interlocking or recon nailing of the femur. To determine the appropriate nail size, an ossimeter, roentgenogram templates, and an x-ray film of the unaffected extremity are necessary for determining canal size at the isthmus and for measuring the length of the femur to aid in determining nail length. The Nail Length Gauge or Guide Wires, available in diameters from 10mm- 17mm, can be used as alternate techniques to determine nail diameter and length.

The proper length of Femur (Femoral) Nail should extend from the tip of the greater trochanter to the epiphyseal scar. The diameter of the femoral nail should match the isthmus in the lateral x-ray projection. The surgeon should review the x-ray to assure that there are no unusual anatomic variations.

Patient Positioning and Radiographic Control

The patient may be placed in either the supine or the lateral decubitus position.

In multiple trauma patients, the supine position may be used for easier access to the airways as well as to facilitate the treatment of other injuries. The supine position also facilitates fracture reduction and rotational alignment of the femur. The disadvantage to the supine position is that it impairs access to the tip of the greater trochanter for insertion of the nail. It is essential to obtain excellent A/P and lateral images of the femoral head and neck prior to beginning the surgery regardless of which patient position is used.

The use of image intensification or other x-ray imaging is required. The image intensifier should be steriledraped and may be positioned from either the contralateral or ipsilateral side of the operating table. Confirm visualization of the hip as well as
the shaft of the femur using image intensification before prepping and draping. Bend the patient’s torso away from the affected extremity to improve access to the greater trochanter. If access to the greater trochanter is still inadequate, adduct the affected leg. However, to achieve proper alignment of the fracture, this adducted position must be corrected prior to insertion of the nail.

Incision and Exposure

Begin the skin incision 1cm proximal to the greater trochanter and carry it proximally about 5cm in line with the gluteus maximus muscle. A larger incision may be desired for obese patients. Split the fascia of the gluteus maximus in line with its fibers. Identify the subfascial plane of the gluteus medius, and palpate the posterior tip of the greater trochanter. Retract the muscles to facilitate visualization of the piriformis fossa This may be difficult in the obese patient, especially if flexion causes the tip of the trochanter to lie against the ilium. Positioning techniques used to expose the tip of the trochanter include adduction of the leg and positioning of the patient’s torso away from the affected extremity.

Creating the Entry Portal

Locating the correct entry portal in the piriformis fossa is extremely important. For the interlocking procedure, place the Awl at the piriformis fossa and check its position with A/P and lateral views. For the recon procedure, place the Awl in the anterior portion of the piriformis fossa approximately 5mm anterior to the position you would choose when doing a standard femoral nailing . This will facilitate screw placement in the center of the femoral neck.

Check the position of the awl with both A/P and lateral images before creating the portal. On the A/P image, the awl should lie at the base of the femoral neck adjacent to the greater trochanter. On the lateral view, it should be oriented just posterior to the center of the femoral neck. When the correct position is achieved, rotate the Awl to create the entry portal for the Ball-Tip Guide Wire. If using the Long Cannulated Awl, the 2.5 mm Ball-Tip Guide Wire can be inserted through the Awl.
An alternative method is to insert a 3 mm Steinmann Pin into the piriformis fossa while checking the position with A/P and lateral image intensification. The Steinmann Pin must lie at the base of the femoral neck just medial to the greater trochanter on the A/P view, and oriented just posterior to the center of the femoral neck on the lateral view. Seat the Steinmann Pin well into the proximal femur and use the optional 9 mm Trochanteric Reamer to create the entry portal.

Guide Wire Replacement and Reaming

Attach the 2.5 mm Ball-Tip Guide Wire to the Wire-Grip T-Handle and tighten. To aid in manipulation, bend the tip of the Guide Wire at about a 10˚ angle 5cm from the end. Insert the Guide Wire through the entry hole and manipulate it down the proximal femur. At the fracture site, manipulate the Guide Wire under C-arm control. Once in the distal canal, pass the wire to its final position in the epiphyseal scar. If reduction of the abducted and flexed hip is difficult, place pressure on the anterior aspect of the proximal fragment either with the hand or directly with an instrument. The Reduction Finger can be used to assist in femoral fracture reduction. To use the Reduction Finger, advance the Ball-Tip Guide Wire and ream the proximal segment. Pass the Reduction Finger over the Ball-Tip Guide Wire. Manipulate the fracture externally While using the Reduction Finger internally to aid in fracture reduction. Once the Ball-Tip Guide Wire has passed through the fracture site, the Ball-Tip Guide Wire is advanced to epiphyseal scar. If the Ball-Tip Guide Wire can not advance through the fracture site, the ball tip of the Guide Wire should be bent
slightly and then reinserted to aid in internal reduction.

Determine the proper nail length by placing a second guide wire of equal length at the greater trochanter. The length of the wire that is not overlapping is the correct nail length. The 50cm Ruler or ossimeter may be used for an accurate measurement. Another way to measure the length is to use the C-arm to position the 0 mark on the metal ruler at the tip of the trochanter. Then read the correct length at the epiphyseal scar directly off the metal ruler. Alternatively, the IM Nail Length Gauge can be used to measure the appropriate Nail length through measurement of one 100cm Guide Wire. To use, place a 100cm Ball-Tip Guide Wire down the medullary canal. Slide the IM Nail Length Gauge over the Guide Wire, ensuring that the distal portion of the gauge is resting on the piriformis fossa in order to determine correct nail length. Nail length is determined by noting the location of the remaining Guide Wire and reading the Nail Length Gauge at that particular location. If the length indicated is between two available nail sizes, it is recommended that the shorter Femur (Femoral) Nail be chosen.

Remove the Wire-Grip T-Handle, and place a intramedullary reamer over the guide wire. The Intramedullary Reaming System is a system of one-piece reamers ranging in size from 7 mm diameter to 20 mm diameter in half millimeter increments. Each reamer is composed of a fluted reamer head, a shaft and a quick-connect drive end. The quick-connect end can be connected to a manual or powered driver. The width of the isthmus of the medullary canal is determined by preoperative x-ray examination. The instrument with the smallest possible diameter is used for initial reaming into the medullary canal. Reamers with a diameter of 5 mm to 7.5 mm use a 2.5 mm Ball-Tip Guide Wire while reamers with a diameter of 8 mm to 20 mm use a 3.0 mm Ball-Tip Guide Wire. As reaming continues, the reamer size should be increased by 0.5 mm or 1.0 mm increments until an opening of the desired size is obtained.

Femur (Femoral) Nail Insertion

Select the appropriate sized Femur (Femoral) Nail. Attach the selected nail to the appropriate left or right Femoral Proximal Targeting Guide. Insert the Femoral Locking Bolt through the barrel of the Proximal Targeting Guide. Using the thumb or finger to apply a steady downward pressure on the Locking Bolt, hand-tighten the Locking Bolt into the proximal end of the nail. Use the Pin Wrench to ensure that the locking mechanism is tightened securely. A keyway in the proximal end of the nail will help ensure proper alignment of the Guide and nail. The Lock Washer mechanism will prevent the Locking Bolt from loosening during the insertion of the nail. Tighten until the Lock Washer is flattened between the Guide and the Locking Bolt.

Interlocking Application
Verify proper alignment of the construct by inserting the 5mm Femoral Drill Bushing into the 8mm Femoral Screw Bushing. Insert the two nested bushings through the interlocking hole. Insert the 5mm Drill into the bushing and through the interlocking hole. When the device is properly aligned, the drill will pass through the proximal hole of the nail and will not contact the nail. Place the selected nail over the Ball-Tip Guide Wire and into the femur. Do not strike the guide directly to seat the nail. Screw the Threaded Driver or the Slaphammer into the back end of the Locking Bolt or onto the offset threaded drive. Begin seating the nail using gentle impaction. The Slotted Mallet can be used with the Threaded Driver to make slight upward adjustments in depth. While impacting the nail, use the Femoral Proximal Guide to maintain the proper rotation during impaction. Use caution when crossing the fracture site. Visualize the fracture in two planes with image intensification to assure proper passage of the nail into the distal fragment. Reduce the force of impaction as the proximal end of the nail approaches the greater trochanter.

Recon Application
When performing the recon procedure, slide a 14 in. Steinmann Pin percutaneously along the anterior aspect of the trochanter, parallel to the femoral neck. Verify pin placement with the C-arm. This will help to identify the anteversion of the neck. During the insertion, the Femoral Proximal Guide must remain parallel to this pin to ensure proper anteversion for the locking screws. If excessive resistance is encountered during nail driving, remove the Femur (Femoral) Nail and check the size of both the reamer and the nail. Once proper sizing has been confirmed, the surgeon may choose to over ream the canal or select a smaller size nail. Continue to seat the nail until it is flush with the trochanter. When the nail is fully seated, REMOVE THE GUIDE WIRE so that it does not get trapped in the bone. Remember, it might be concealed inside the driver or Slaphammer. Reassess the integrity of the Locking Bolt – Nail connection and re-tighten with the Pin Wrench if necessary.

Verify proper alignment by inserting the 3.2mm Femoral Pin/Drill Bushing into the 5mm Femoral Drill Bushing; then insert these two nested bushings into the 8mm Femoral Screw Bushing. Place the three nested guide bushings through one of the recon holes in the Femoral Proximal Guide. Insert the 3.2mm, 14in. Steinmann Pin through the inner bushing. When the device is properly aligned, the Steinmann Pin will pass through the proximal hole of the nail and will not contact the nail.

Proximal Locking

Screw the 5mm Femoral Drill Bushing, into the 8mm Femoral Screw Bushing, and insert them into the Femoral Proximal Guide. Insert the 5mm Femoral Drill, into the assembled bushings and drill until the medial femoral cortex is penetrated. Remove the 5mm Femoral Drill Bushing, leaving the 8mm Femoral Screw Bushing in place. Use the Proximal Screw Depth Gauge to determine screw length. Use the T-Handle Screwdriver to insert the appropriate length screw, to the correct reference line on the T-Handle Screwdriver. Use the C-arm to check the position of the screw and tighten it appropriately. Remove the screwdriver and the 8mm Femoral Screw Bushing. Take A/P and lateral C-arm views to check for correct positioning. If using a second Proximal screw, repeat the previous technique. Disengage the Locking Bolt from the nail using the Pin Wrench.

For Recon Application
Correct rotation of the Femur (Femoral) Nail is imperative for retrograde insertion of the two screws through the nail and into the femur. Be sure that the nail is inserted to the correct depth to allow placement of both screws with the correct anteversion. Screw the 3.2mm Proximal Pin/Drill Bushing, into the 5mm Femoral Drill Bushing. Screw this construct into the 8mm Femoral Screw Bushing, and insert the assembled three bushings into the inferior recon hole of the Femoral Proximal Guide to the level of the skin. Make an incision in the skin and fascia at this point and continue to insert the bushings until contact is made with the lateral femoral cortex. Drill a 14in. Steinmann Pin into the femoral head to the required level to achieve fracture fragment stability, without penetrating the femoral head cortex. Verify the proper position and anteversion of the pin with A/P and lateral C-arm views. Avoid excessive twisting or torquing of the Femoral Guide to ensure proper targeting. If the position is not correct, remove the pin and adjust the nail rotation and/or nail depth. Verify the new pin placement with the C-arm.

Assemble the second set of three bushings in the same fashion and place them into the superior hole of the Femoral Proximal Guide. Drill the second 14in. Steinmann Pin in to the bone and verify its position with the C-arm. If the position is unacceptable, remove both Steinmann Pins and reposition the nail. If the correct position is obtained, remove the Threaded Driver or Slaphammer. Also remove the inferior Steinmann Pin and the 3.2mm Proximal Pin/Drill Bushing. Insert the 5mm Femoral Drill, into the 5mm Femoral Drill Bushing. Drill the inferior proximal screw hole while monitoring image intensification to prevent penetration of the femoral head. Read the appropriate screw length directly from the calibrated Femoral Drill. Remove the 5mm Drill and Femoral Drill Bushing. Insert the Recon Screw Counterbore through the outer 8mm Femoral Screw Bushing and counterbore. The blunt end of the Counterbore serves as a stop.

Screw length may alternatively be measured using the Proximal Screw Depth Gauge. Select a screw equal to the measured length to avoid penetration of the joint. Another gauge that can be used to measure screw length is the Cannulated Depth Gauge. Slide the Cannulated Depth Gauge over the Steinmann Pin, i.e., the inferior of the two Steinmann Pins if two pins are used, until the gauge contacts the lateral aspect of the femur. Assess that the gauge is seated against the bone using the C-arm. Read and record the length of the Steinmann Pin from the calibrated depth gauge. Remove the counterbore using the T-Handle Screwdriver, insert the appropriate length 5.5mm Partially Threaded Recon Screw through the outer bushing to the level of the correct reference line on the T-Handle Screwdriver. Use the C-arm to ensure proper seating of the locking screw well within the femoral head. Tighten it appropriately.

The first screw should lie in the inferior neck to allow room for the second screw to be placed. This may be difficult in small patients or in patients with varus hips. Be certain to seat the inferior screw tightly against the medial cortex to prevent varus deformity and to allow for placement of the proximal screw. Remove the T-Handle Screwdriver and the Femoral Bushing. Take A/P and lateral C-arm views to check for correct positioning. Repeat the same procedures for insertion of the superior
locking screw. Again, observe A/P and lateral C-arm views to ensure proper seating within the femoral head and neck. Using the Pin Wrench, loosen and remove the Locking Bolt and Femoral Proximal Guide.

Distal Locking

The distal locking screws may be inserted with a freehand technique using the Freehand Targeting Device. Insert an appropriate size Trocar into the Freehand Targeting Device. Finger tighten the set screw. Choose the appropriate locking hole based on the need for dynamization. The superior locking hole on Femur (Femoral) Nail is used for static locking, while the distal locking hole is used for dynamic locking. If static locking is preferred, but there is a potential need for later dynamization, insert screws in both locking holes. The locking screw in the static hole can then be removed to achieve later dynamization. For success with this technique, proper placement of the lateral x-ray beam is critical. Position the C-arm so the locking hole of the nail appears perfectly round on the monitor.

When this is achieved, bring the tip of the Trocar to the skin and use the C-arm to center it over the hole. Make a lateral stab wound opposite the appropriate locking hole, and dissect down to bone. Bring the tip of the Trocar to the bone and center it over the locking hole using the C-arm. Align the Trocar with the axis of the x-ray beam. Drive the Trocar into the bone and across the hole in the nail in line with the lateral x-ray beam, but do not penetrate the medial cortex. Remove the Targeting Device by loosening the set screw. Verify Trocar placement in both the A/P and lateral planes. After it has been correctly placed, remove the Trocar. The path of the Trocar in the bone acts as a pilot hole for the appropriate size drill. Attach the appropriate drill (same size as the Trocar) to the Freehand Targeting Device. Insert the drill into the pilot hole made by the Trocar. Before drilling through the medial cortex, check the A/P and lateral C-arm image to assure that the drill is in the hole in the nail. Then drill through the medial cortex.

Remove the drill and insert the Distal Screw Depth Gauge. The length of the screw is determined by reading it directly off the Distal Screw Depth Gauge. Select an appropriate length screw to ensure adequate engagement of the medial cortex. Insert the appropriate size Screw using the Screwdriver.If desired, insert the second screw in the second locking hole of the nail in an identical manner. Check the position of both screws with the C-arm in the A/P and lateral planes. Bushings are available that can be used with the Freehand Targeting Device. A separate radiolucent Bushing Insert is available to aid in targeting.

More Products from Interlocking Nails

Femur (Femoral) Nail Contraindications

Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

  • Any active or suspected latent infection or marked local inflammation in or about the affected area.
  • Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
  • Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.
  • Material sensitivity, documented or suspected.
  • Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to
    failure of the device itself.
  • Patients having inadequate tissue coverage over the operative site.
  • Implant utilization that would interfere with anatomical structures or physiological performance.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
  • Other medical or surgical conditions which would preclude the potential benefit of surgery.
  • All associated diseases which could endanger the function and success of the Femur (Femoral) Nail.

Warnings and Precautionary for Femur (Femoral) Nail

Before using Femur (Femoral) Nail, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.

Femur Nail is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Femur Nail assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.

Improper use of  Femoral Nail can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.

It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of implants.

Factors which could impair the success of the operation:

  • Allergies to implanted materials.
  • Localized bone tumours.
  • Osteoporosis or osteomalacia.
  • System disease and metabolic disturbances.
  • Alcohol and drug abuse.
  • Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
  • Patients who are mentally unable to understand and comply with the doctor’s instructions.
  • Poor general health.

Possible Adverse Effects

The following adverse effects are the most common resulting from implantation:

  • Loosening of the Femoral Nail, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
  • Early and late infection.
  • Further bone fracture resulting from unusual stress or weakened bone substance.
  • Temporary or chronic neural damage resulting from pressure or hematomata.
  • Wound hematomas and delayed wound healing.
  • Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
  • Heterotopic ossification.
  • Pain and discomfort due to presence of the Femur (Femoral) Nail.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Femur (Femoral) Nail

The operating planning is carried out following a thorough clinical evaluation of the patient, Also, x-rays must be taken to allow a clear indication of the bony anatomy and associated deformities. At the time of the operation, the corresponding implantation instruments in addition to a complete size of Femur (Femoral) Nail must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of implants. It is important to determine pre-operatively whether the patient is allergic to any of the implant materials. Also, the patient needs to be informed that the performance of the device cannot be guaranteed as complications can affect the life expectancy of the device.

Femur (Femoral) Nail Precautions

  • Confirm functionality of instruments and check for wear during reprocessing. Replace worn or damaged instruments prior to use.
  • It is recommended to use the instruments identified for this Femur Nail.
  • Handle devices with care and dispose worn bone cutting instruments in a sharps container.
  • Always irrigate and apply suction for removal of debris potentially generated during implantation or removal.

Femur (Femoral) Nail Warnings

  • Femur (Femoral) Nail can break during use (when subjected to excessive forces). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail.
  • Instruments, screws and cut plates may have sharp edges or moving joints that may pinch or tear user’s glove or skin.
  • Take care to remove all fragments that are not fixated during the surgery.
  • While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Femoral Nail removal should be followed by adequate post-operative management to avoid refracture.

Femur (Femoral) Nail General Adverse Events

As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the Femur (Femoral) Nail, reoperation.

What is a femoral shaft fracture?

A femoral shaft fracture is a break of the femur (thighbone). Femoral nailing is an operation to fix a broken femur using a metal rod. The metal rod is called a femoral nail (also called an intramedullary or interlocking nail)

Your surgeon has recommended femoral nailing to treat your broken femur. However, it is your decision to go ahead with the operation or not. This document will give you information about the benefits and risks to help you make an informed decision. If you have any questions that this
document does not answer, you should ask your surgeon or any member of the healthcare team.

How does a femoral shaft fracture happen?

Road accidents and sport are the cause of most femoral shaft fractures. You can lose up to a litre (about two pints) of blood into the thigh muscle at the time of the injury. Sometimes the injury causes the bone to break through the skin. This is known as an open or compound fracture.

What are the benefits of surgery?

The main benefits of surgery are that you will only need a short stay in hospital and you will be able to use your leg sooner. Surgery will also make sure your bone heals in a good position.

Are there any alternatives to femoral nailing?

A femoral shaft fracture can be treated in traction (using a heavy weight fixed to the leg to pull the bones into position until they heal). However, some fractures are difficult to hold in a good position without surgery. If you have an open fracture, you will almost certainly need an operation. Your surgeon can sometimes fix your femoral shaft fracture with an external fixator or a plate and screws instead of a femoral nail. They will explain why they recommend femoral nailing for your fracture.

What will happen if I decide not to have the operation?

You will have your leg in traction. You may need to stay in hospital for a long time. This can lead to complications such as blood clots, chest infection and pressure sores. After a number of weeks, your leg may be put into a large plaster cast (called a hip spica) or a brace. The fracture will take about three to six months to heal. You will need physiotherapy to learn to walk again because your muscles will have become weak after spending such a long time in bed.

What does the operation involve?

The healthcare team will carry out a number of checks to make sure you have the operation you came in for and on the correct side. You can help by confirming to your surgeon and the healthcare team your name and the operation you are having.

A variety of anaesthetic techniques is possible. Your anaesthetist will discuss the options with you and recommend the best form of anaesthesia for you. You may also have injections of local anaesthetic to help with the pain after surgery. You may be given antibiotics during the operation to reduce the risk of infection. The operation usually takes between an hour and an hour and a half.

Your surgeon will push the femoral nail down the inside of the bone, either through a cut on the side of the hip or on the front of the knee. The nail goes across the break and holds it in position. The nail is held in the bone by locking screws that pass through holes in the nail. If you have an open fracture, your surgeon will clean the skin wound thoroughly during the operation to reduce the risk of infection. If the skin is badly damaged, you may also need one or more plastic surgery operations. At the end of the operation, your surgeon will close the skin with stitches or clips.

What should I do about my medication?

You should let your doctor know about all the medication you are on and follow their advice. This includes herbal remedies and medication to control diabetes and blood pressure. If you are on beta-blockers, you should continue to take them as normal. You may need to stop taking warfarin or clopidogrel before your operation. Anti-inflammatory painkillers may stop the fracture healing properly, so it is better not to
take these if possible.

What can I do to help make the operation a success?

If you smoke, stopping smoking may reduce your chances of getting complications and will improve your long-term health. Nicotine is known to stop fractures from healing. Regular exercise should help you recover and improve your long-term health. Before you start exercising, ask a member of the healthcare team or your GP for advice. You can reduce your risk of infection in a surgical wound by keeping warm around the time of your operation. Let a member of the healthcare team know if you are cold.