Unlike other total disc replacement devices, XL TDR® is a total disc replacement that is implanted from the patient's side, an approach which may improve 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 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 may minimize the risk of potential complications such as vascular injury, major bleeding, intestinal injury, ureteral injury, sexual dysfunction, and postoperative back muscle pain.
Purpose of the Research
Nuvasive seeks to demonstrate the safety and efficacy of the XL TDR device, compared to fusion procedures.
Who is Eligible to Enroll?
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.
For further details including exclusion criteria and assessment information please visit the Nuvasive website. Only a clinical research study staff member can determine if you are eligible for this clinical research study.
As with any spine surgery, there are potential benefits and possible risks. Discuss these with your doctor to determine if you are a candidate. Caution; this is an investigational device and is limited by Federal (U.S.) Law to investigational use.
What is the Visit Schedule?
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.