Category: Deformity Correction
A common sentiment among spine surgeons engaged in the treatment of paediatric patients and small stature patients and is that larger deformities in smaller anatomies are one of the most challenging issues in spinal surgery. Concerns over implant profile and implant selection, along with the ability to choose instrumentation based on patient size and pathology are fairly common when treating these patient groups.
Seeking to eliminate these concerns, DePuy Synthes Spine has developed the most complete rod-hook-screw system specifically designed for these smaller anatomies: the EXPEDIUM® 4.5 System.
The EXPEDIUM® 4.5 System exhibits the lowest profile in DePuy Synthes Spine Thoracolumbar Portfolio, making it a useful option for cases in which the surgeon is challenged with implant protrusion and cosmetic problems. In addition, the system combines a variety of screw and hook designs (e.g., polyaxial, uniplanar, etc) and rod materials (i.e., Ti, SS and CoCr Alloy) to offer plenty of instrumentation possibilities for the treatment of even the most complex cases.
As with every product in the EXPEDIUM Portfolio, the clinical experience and pathology knowledge of renowned paediatric spine surgeons is reflected in every aspect of the product.
The EXPEDIUM System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM System is intended for non-cervical pedicle fixation and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
Active systemic infection or infection localised to the site of the proposed implantation are contraindications to implantation.
Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert.
WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES
Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
A. The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation.
B. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labour, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully.
C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.
D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy.
E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time.
F. Smoking. Patients who smoke have been observed to experience higher rates of pseudoarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.
|EXPEDIUM - BE A CUT ABOVE|
|Low implant profile||Decreases soft tissue disruption|
||Appropriate implant option is available for each patient’s anatomy and pathology, and surgeon’s preferred correction technique|
|Instruments specifically designed for smaller anatomies||Instruments provide the precision & tactile feel that is critical for procedures in smaller anatomies|
Common implant features with other systems in the EXPEDIUM Portfolio:
|Interconnectivity with other EXPEDIUM products||Offers the ability to create hybrid constructs and simplifies revision cases.|