XL TDR®
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
Most individuals with degenerative disc disease will find relief through medication, chiropractic care, and/or physical therapy without requiring surgical care. However, in some instances, nonsurgical 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 and typically replaced with a device which restores the height lost by the degenerative disc. The 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 on 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 in treating one-level degenerative disc disease.
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.
What makes XL TDR® different?
Although the XL TDR® device has distinct design differences from other lumbar total disc replacement devices, the key difference is in the way the surgeon surgically approaches the spine. Other total disc replacement devices are implanted through the front of the body (abdomen), requiring delicate manipulation of the major blood vessels and disruption of the anterior longitudinal ligament (ALL), a key stabilizing structure in the lumbar spine. Surgeons implant the XL TDR® device through a lateral (side) approach to the spine - an approach that has been proven in years of clinical experience. This minimally disruptive approach minimizes postoperative pain and significantly reduces recovery normally associated with traditional "open" approaches. With minimal tissue disruption from the approach, surgeons using XL TDR® aim to safely restore disc height, relieve pain, and maintain motion in the spine within a natural range.
Who can participate in this clinical study?
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:
- 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).
- lnterest in becoming pregnant within the follow-up period of the study. (You will also be excluded if you are currently pregnant.)
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.
Participants enrolled in this study and receiving the investigational device will not be responsible for any of the medical costs associated with the study. The investigational device will be provided at no charge. Neither the participant nor the participant's insurance company will be billed for the surgery or any additional tests or assessments associated with this clinical research study.
Is there any cost for participants?
Where is the XL TDR® clinical research study being conducted?
There are clinical research study sites located nationwide. Please call 573-636-9000 to speak with our Research Coordinator and to determine your eligibility for participation at Spine Midwest. You may also call 888-674-2326 (toll free) or visit www.xlmotion.com for more details about other site at which this clinical research study is being conducted. This multi-center clinical research study is a prospective, controlled trial designed to evaluate the safety and efficacy of
XL TDR® by comparing the outcomes of patients to outcomes of traditional spinal fusion surgery.
As with any spine surgery, there are potential benefits and possible risks. Discuss these with your doctor to determine if you are a candidate.
Minimally Invasive Surgery for Degenerative Scoliosis
Degenerative scoliosis is a medical condition where a right-left curvature of the spine develops due to degeneration of the disc. This misalignment of the spine can cause back and/or leg pain due to muscle fatigue and nerve impingement. Patients suffering from scoliosis often undergo surgery to restore proper alignment and disc height. During the procedure the surgeon removes most of the disc between the two or more vertebrae that are to be stabilized and implants a spacer to restore correct spinal alignment. The surgeon also implants bone-forming cells that bridge the space between the vertebrae and allow the bones to grow together. Increased stability and restoration of alignment often result in significant pain relief.
The Surgical Procedure
The minimally invasive approach is an option for lumbar fusion surgery candidates interested in quicker recovery and rapid return to normal activity. With the minimally invasive procedure, the spine is approached from the side of the body, through small incisions, avoiding sensitive back muscles, bones, and ligaments, minimizing risk of serious neural and/or vascular damage. The result of this minimally invasive approach is less surgical blood loss and reduced postoperative pain. In general, minimally invasive surgery results in quick recovery and return to normal activity.
Solas Registry Database
Spine Midwest is a research institution dedicated to the improvement of medical and surgical care.
We are collecting data about the outcomes of operative and non-operative care related to spinal disease. In collaboration with the Society for Lateral Access Surgery (SOLAS), Spine Midwest will pool this data with surgeons around the world to evaluate methods of treatment. In this way, patients and physicians are helping to make sure that the care we give to all patients will always be the very best. Special data related to Quality-adjusted life year (QALY) measurements (meaurement of the personal and societal burden of a disease) is collected and compared between centers and methods of care. This very special data will help all surgeons ensure that not only is the care given effective for patients personal well being, but that it helps restore their quality of life in all aspects.