The Gamma Nail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). Lag screw is also indicated for rotationally unstable fractures.
The Gamma Nail has a medial-lateral angle of 6°. This allows insertion at the tip of the greater trochanter.
Several distal locking options: Static or dynamic locking can be performed via the aiming arm with Gamma small . The Gamma long additionally allows for secondary dynamization.
The Gamma Nail is available in 4 sizes
Inserting the Gamma Lag Screw compacts the cancellous bone providing additional anchoring, which is especially important in osteoporotic bone.
Increased stability caused by bone compaction around the Gamma Lag Screw has been biomechanically proven to retard rotation and varus collapse. Biomechanical tests have demonstrated that the Lag Screw had a significantly higher cut-out resistance in comparison with commonly-used screw systems.
All surgical steps required to insert the Lag Screw are performed through lateral incision.
Length 170 mm
Dia 10mm, 11mm and 12mm
Length 180 mm
Dia 10mm, 11mm and 12mm
Length 200 mm
Dia 10mm, 11mm and 12mm
Length 240 mm to 440 mm
Dia 10mm, 11mm, 12mm, 13mm and 14mm , Left and Right
Indications
Contraindications
Indications
Contraindications
When treating femoral fractures, the gamma nail has a number of benefits. First of all, it stabilizes the fractured bone right away, lowering the possibility of additional displacement or harm. Early mobility and weight-bearing are made possible by this stability, which may hasten healing and enhance functional outcomes. Gamma nail design also minimizes damage to surrounding soft tissues, which lessens postoperative pain and problems.
Gamma Nail Instruments Set contains instruments required for treatment of proximal femoral fractures in geriatric osteoporotic patients using Gamma Nails.
Gamma Nail Instruments Set Features:
Below are list of items in Gamma Instruments Set.
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Non-clinical testing has demonstrated the Gamma Nail Titanium is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 1.5 T or 3.0 T
• Maximum spatial field gradient of 3000 gauss/cm (30 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
• Scan time restriction: maximum 15 minutes of continuous RF (a sequence or back to back series/scan without breaks) followed by a wait time of 15 minutes if this limit is reached.
Under the scan conditions defined above, the Gamma3 Titanium Nailing System is expected to produce a maximum temperature rise of less than 6.9 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 28mm from the Gamma3 Titanium Nailing System when imaged with a gradient echo pulse sequence and a 1.5 T MRI system.
Non-clinical testing has demonstrated the Gamma3 Stainless Steel Nailing System is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T or 3.0 T
• Maximum spatial field gradient of 2000 gauss/cm (20 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
• Scan time restriction: maximum 15 minutes of continuous RF (a sequence or back to back series/scan without breaks) followed by a wait time of 15 minutes if this limit is reached.
Under the scan conditions defined above, the Gamma3 Stainless Steel Nailing System is expected to produce a maximum temperature rise of less than 6.9 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 79 mm from the Gamma3 Stainless Steel Nailing System when imaged with a gradient echo pulse sequence and a 1.5 T MRI system.
To achieve optimal placement and stability, the surgical approach for inserting a Gamma Nail includes a number of important steps. While the details of the surgery may differ slightly based on the patient’s condition and the surgeon’s preferences, the following is a rough outline of the surgical technique:
Following the procedure, the patient is kept under observation in the recovery area prior to being moved to a hospital room. Pain control, infection and complication monitoring, and physical therapy to support early mobilization and rehabilitation are common postoperative care measures.
It’s crucial to remember that an orthopedic surgeon with training and experience in this treatment should execute the surgical technique for inserting a gamma nail. Since every patient’s case is different, the surgeon will customize the surgical strategy to meet each person’s unique demands and circumstances.
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:
Before using Gamma 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.
Nail is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Gamma 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 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.
The following adverse effects are the most common resulting from implantation:
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 Gamma 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.
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 Gamma Nail, reoperation.
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.
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.
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.
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.
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.
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 Gamma Nail 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.
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.
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.
TENS Nail (Titanium Elastic Nail)
