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A Study Investigating Minimally Disruptive Motion Preservation For The Lumbar Spine
Introducing a new surgical solution.
Unlike other total disc replacement devices, XL TDR® is a total disc replacement that is implanted from the patient's side, an approach which radically improves the patient experience. In conjunction with SOLAS,™ the Society of Lateral Access Surgery, NuVasive® is pleased to be sponsoring a clinical study designed to demonstrate the safety and efficacy of XL TDR.
XL TDR seeks to relieve the painful symptoms associated with lumbar degenerative disc disease. However, instead of achieving pain relief through fusion (immobilization of the spinal segment), XL TDR seeks to relieve pain while restoring height and maintaining motion at the spinal segment. Through thoughtful and careful scientific study, we seek to demonstrate the safety and efficacy of this device, compared to other fusion procedures.
What Is Lateral Access?
Lateral access is a minimally disruptive approach to the spine from the side of the body. With sophisticated nerve avoidance technology, the surgeon approaches the spine through a small incision or two on the patient's side, avoiding the abdominal incision of traditional anterior approaches, and the dissection or retraction of the sensitive back muscles, typical of traditional posterior approaches. The lateral approach minimizes or avoids the risk of potential complications such as vascular injury, major bleeding, intestinal injury, ureteral injury, sexual dysfunction, and postoperative back muscle pain.
XL TDR is building on the success of XLIF,® the lateral approach spine fusion procedure introduced by NuVasive in 2003 that has been successful in treating thousands of patients suffering from a variety of spinal disorders.
What Is Degenerative Disc Disease?
As humans age, one or more of the shock-absorbing, flexible discs between the vertebrae in the lower back begin to deteriorate. Small cracks or tears may form that can lead to disc bulge or rupture. The discs may also lose fluid, resulting in a smaller space between vertebrae. These conditions are referred to as degenerative disc disease (DDD) and may cause an individual pain, numbness, or difficulty walking, reaching, bending over, or twisting.
Current Treatments
Many people who suffer from this condition rely on medication, chiropractic care, and/or physical therapy to relieve the pain. However, in some instances, non-surgical care alone is inadequate due to the condition’s severity, possibly resulting in permanent impairment. In other instances, non-surgical care alone may not relieve the painful symptoms of degenerative disc disease.
When non-surgical treatment either ceases to provide relief for the patient or is not indicated, surgery may be considered. The most common current surgical option for lumbar DDD is spinal fusion. In this procedure, the degenerative disc is removed. Because this "cushion" is no longer present, the affected vertebrae are literally "fused" together so that motion can no longer occur. The degenerative disc is typically replaced with a device which restores the height lost by the degenerative disc. This device also facilitates a fusion between the two vertebrae, eliminating motion between those vertebrae. The elimination of the diseased disc and the restoration of height are intended to relieve the pain.
XL TDR® Is an Investigational Device That May Be Right for You.
NuVasive® has developed a minimally disruptive surgical device called XL TDR for the treatment of DDD. Participants are now being enrolled in a clinical research study for this total disc replacement device. The study is intended to evaluate the device's safety and effectiveness.
What Is XL TDR?
XL TDR is a metallic prosthetic joint, or total disc replacement, that replaces a degenerative intervertebral disc. Like fusion, total disc replacement is designed to supplant the primary function of the disc – to maintain vertebral spacing to protect the nerves and spinal cord. Unlike fusion, though, total disc replacement seeks to maintain one of the secondary functions of the disc – providing motion in the spine. Once implanted between the vertebrae, XL TDR is designed to relieve pain and restore height while replicating the motion characteristics of an intact healthy disc.
Where Is the XL TDR Clinical Research Study Being Conducted?
There are clinical research study sites located nationwide. Read more about this clinical research study at www.clinicaltrials.gov. This multi-center clinical research study is a prospective, controlled trial designed to evaluate the safety and efficacy of XL TDR by comparing outcomes of patients with this device to literature-reported results of similar devices that have been approved by the FDA to treat disc degeneration.
Are You Eligible?
Inclusion Criteria
Participants must be 18-70 years of age and meet at least the following criteria:
 Diagnosis of symptomatic degenerative disc disease (DDD) at one (and only one) of the following levels of the lumbar spine:
- L3-L4
- L4-L5
Preoperative Disability Index above a limit determined by a physician’s assessment and questionnaire.
Unresponsive to non-surgical treatment for 6 months.
Exclusion Criteria
Some people who meet the criteria listed above may not be eligible to participate in this clinical research study. This includes any person who has at least one of the following criteria, among others:
- Symptomatic multilevel lumbar DDD.
- Previous or other lumbar spinal surgery at any level, except prior discectomy, laminotomy, or nucleolysis at the same level.
- Another implanted lumbar device.
- Severe osteopenia or osteoporosis.
- Morbid obesity (body mass index >40).
- Interest in becoming pregnant within the follow-up period of the study. (Youwill also be excluded if you are currently pregnant.)
Other Criteria
The criteria listed above are not the only eligibility requirements for this study. Only a clinical research study staff member can determine if you are eligible for this clinical research study.
What are the requirements for participants?
Following the surgery, participants will be asked, and are required, to visit the clinical research study site at regular intervals for a minimum of two years for evaluation by clinical research study personnel.
Find out if you are eligible for this clinical study TODAY by calling
(305) 532-2411 x 2001.
As with any spine surgery, there are potential benefits and possible risks. Discuss these with your doctor to determine if you are a candidate.
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