Locking Trochanter Stabilizing Plate Specification, Uses, Sizes and Surgical Techniques

Locking Trochanter Stabilizing Plate

Locking Trochanter Stabilizing Plate Specification

Locking Trochanter Stabilizing Plate has been designed as an extension to the Dynamic Hip Screw Plate and serves the following functions:

It limits diaphyseal medialisation by fastening onto the greater trochanter.
It enables the insertion of an additional cranial and parallel antirotation screw, which acts as a superolateral tension band. When used, the atirotation screw imposes a slightly more caudal positioning of the screw compared to the standard technique.
It allows for an additional proximal internal fixation of the greater trochanter with locking head screws.
It maintains the dynamization capacity of the Dynamic Hip Screw Plate.

Advantages of angular stability
Locked angle-stable screws can be fixed monocortically, even in soft bone without any risk of screw loosening. Due to the high stability of the screws in the plate, the greater trochanter can be secured as a functional entity without using cerclage wires. Fix the plate over or through the gluteus medius muscle without compressing the bone. As an internal fixator, the plate preserves bone vascularity.

Additional features of Locking Trochanter Stabilizing Plate

Locking Trochanter Stabilization Plate extends the Dynamic Hip Screw Plate and Locking Dynamic Hip Screw Plate constructs to help stabilize the greater trochanter and to facilitate insertion of an anti-rotation screw into the femoral head.

Limits medialization: Provides buttress support to prevent the fracture from medializing and dropping into valgus.
Prevents rotation: 6.5 mm/7.3 mm cannulated screws can be placed through the plate, cranially and parallel to the Dynamic Hip Screw Lag Screw. By putting the anti-rotation screw through the plate, the plate prevents submersion of the screw head into osteopenic bone.
Instead of a cerclage, use locking head screws to achieve an additional proximal internal fixation (cerclage is still possible).
Only one size is required (plate can be cut).
It is easy to bend the plate and adapt it to the individual anatomical conditions.
Plates available in both Titanium and Stainless steel.

Locking Trochanter Stabilizing Plate uses

Locking Trochanter Stabilizing Plate is intended to treat stable and unstable fractures of the proximal femur:

Intertrochanteric
Subtrochanteric
Pertrochanteric
Basilar neck fractures

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Locking Trochanter Stabilizing Plate 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 Locking Trochanter Stabilizing Plate.

Warnings and Precautionary for Locking Trochanter Stabilizing Plate

Before using Locking Trochanter Stabilizing Plate, 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.

Locking Trochanter Stabilizing Plate is made from medical grade materials and are designed, constructed and produced with utmost care. These quality plate 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 implants 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 this plate.

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 implants, 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 Locking Trochanter Stabilizing Plate.
Mechanical failure of the implant, including bending, loosening or breakage.
Migration of implant resulting in injury.

Preoperative Planning for Locking Trochanter Stabilizing Plate

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 set of Locking Trochanter Stabilizing Plate 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.

Locking Trochanter Stabilizing Plate 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 screw.
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.

Locking Trochanter Stabilizing Plate Warnings

Locking Trochanter Stabilizing Plate 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. Implant removal should be followed by adequate post-operative management to avoid refracture.

Locking Trochanter Stabilizing Plate 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 implant, reoperation.

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Locking Trochanter Stabilizing Plate Specification, Uses, Sizes and Surgical Techniques