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The VariAx Elbow implants are indicated for internal fixation of the distal humerus and proximal ulna for the following conditions and procedures: Intra-articular and extra-articular fractures (including non-union) and osteotomy.

The target group for application of the VariAx Elbow implants is skeletally mature patients (according to the judgment of the licensed healthcare professional) with utilization at the appropriate anatomical structures as defined in indications.

• 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 cannot provide adequate support and/or fixation of the devices
• Material sensitivity, documented or suspected
• 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 post-operative care
• Other medical or surgical conditions which would preclude the potential benefit of surgery

Distal humerus

The patient may be positioned in two different ways depending on the clinical condition.

If the injury is isolated:

Lateral decubitus with a bolster to support the arm.

If poly trauma is present:

Supine with the arm placed over the chest.

Olecranon

For isolated olecranon fractures the patient is positioned supine with the arm placed over the chest on a support pad.

Distal humerus

The posterior approach is the standard for distal humerus fractures. Two common techniques for this approach are the triceps splitting and the olecranon osteotomy techniques. The former is the preferred technique of the plate designers.

CAUTION: The ulnar nerve should be explored and protected as part of the surgical approach. The radial nerve may require exploration with proximal shaft extension.

Triceps splitting

A midline incision is made in the triceps aponeurosis from proximally to distally onto the shaft of the ulna. Equal portions of the triceps muscle are reflected medially and laterally with use of sharp dissection to remove the triceps insertion from the olecranon.

Olecranon osteotomy

A chevron (apex distal) osteotomy is performed approximately two centimeters from the tip of the olecranon with an oscillating saw, which is meant to exit in the "bare area" of the joint, the midportion of the trochlear fossa or notch where the olecranon is devoid of cartilage.

Olecranon

An incision is made proximal to distal from the humerus supracondylar region posteriorly to approximately 5 cm distal to the fracture.

CAUTION: Care is taken not to damage the ulnar nerve.

Post-operative

• Post-operative patient activity: These implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time. For this reason post-operative instructions and warnings to patients are extremely important. External immobilization (e.g. bracing or casting) may be employed until X-rays or other procedures confirm adequate bone consolidation.
• The implant is intended to provide temporary stabilization for bones or bone fragments. In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur (e.g. fracture or loosening of the implant or instability of the implant system). Regular post-operative examinations (e.g. X-ray checks) are advisable.
• The risk of post-operative complication (e.g. failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder. For this reason those patients must have additional post-operative follow-up.
• Implant removal should be followed by adequate post-operative management to avoid fracture or refracture of the bone.

Informing the patient

• Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.
• Explain also the need to appear for the post-operative examinations (e.g. X-ray checks) and for the possible explantation of the implant.

The implantation affects the patient's ability to carry loads and her/his mobility and general living circumstances. For this reason, the licensed healthcare professional must counsel each patient individually on correct behavior and activity after the implantation.

• The implant is intended to provide temporary stabilization for bones or bone fragments. In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur (e.g. fracture or loosening of the implant or instability of the implant system).
• Implant removal should be followed by adequate post-operative management to avoid fracture or refracture of the bone.
• The licensed healthcare professional must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.
• Explain also the need to appear for the post-operative examinations (e.g. X-ray checks) and for the possible explantation of the implant.