The TRIUMPH® Lumbar Disc is an articulating artificial disc that consists of two cobalt chrome alloy (CoCrMo) components. TRIUMPH® has two endplates and a rotating core that are inserted as one single piece. The outer, bone-contacting surfaces have multiple serrated keels for fixation into the vertebrae and a titanium plasma porous coating to permit bony ongrowth. The TRIUMPH® Lumbar Disc is designed to allow motion in flexion and extension up to 24° (+/- 12°), in lateral bending up to 24° (+/- 12°), and in axial rotation up to 29° in either direction; however, motion is mediated by anatomic constraints which limit the axial rotation to approximately 3° in either direction.
The TRIUMPH® Lumbar Disc is indicated for reconstruction of the spinal disc following discectomy and decompression in skeletally mature patients with degenerative disc disease (DDD) at one level from L1 to S1.
The TRIUMPH® Lumbar Disc was developed due to the clinical need for an artificial disc that allows physiologic motion utilizing a common, posterolateral surgical approach to the spine. With the posterolateral approach, a spine surgeon can access posterior pathology that may be difficult to reach anteriorly through the abdomen. The anterior approach has an inherent risk of complications such as vascular injury and organ damage. The posterior approach also has an inherent risk of complications such as nerve or spinal cord injury.
IDE Clinical Trial
The Food and Drug Administration has determined that the TRIUMPH® Lumbar Disc is an investigational device in the United States. Thus, Globus Medical is sponsoring a Clinical Trial under an Investigational Device Exemption (IDE) to evaluate TRIUMPH® for the treatment of lumbar degenerative disc disease. Patients who are interested in enrolling in the study must be between the ages of 18 and 65, have lumbar degenerative disc disease at one spinal level from L1 to S1, have had at least six months of conservative treatment, are able to attend all follow-up exams, and meet further eligibility criteria.
The patient is placed under anesthesia and positioned prone (on their stomach). An incision is made in the lower back and a discectomy is performed to remove the degenerative spinal disc, leaving the outer rim of the disc intact. After the spine is decompressed posteriorly, the TRIUMPH® Lumbar Disc is inserted to take the place of the diseased disc.
TRIUMPH®: Frequently Asked Questions
Q: What is the purpose of the study?
A: To determine if the TRIUMPH® Lumbar Disc is safe and effective for treating degenerative disc disease in the lumbar spine (lower back).
Q: How is TRIUMPH® different from the lumbar artificial discs that are already approved by FDA?
A: The artificial discs currently approved for use in the lumbar spine in the United States must be implanted using an anterior surgical approach (through the patient’s abdomen). The primary difference is that the TRIUMPH® device is implanted through a posterolateral surgical approach. The goal is to provide surgeons with an effective treatment option that addresses posterior clinical symptoms while allowing motion at the treated spinal level.
Q: Are most spine surgeons familiar with a posterior/posterolateral surgical approach to the spine?
A: Most spine surgeons should be familiar with the posterior/posterolateral surgical approach. However, every surgeon’s level of experience and expertise in a given condition can vary based on their individual education and the patient population they treat. The techniques used to access and decompress the spine to relieve pressure are very similar, whether the surgeon is implanting TRIUMPH® or fusing the segment. Surgeons who participate in this clinical trial are trained in the proper implantation technique for TRIUMPH® and are experiencedwith a posterior/posterolateral surgical approach.
Q: Can I participate in this study?
A: Talk to your doctor about whether your medical condition is appropriate for this study. If your condition qualifies and you are interested in participating, you will be asked to read and sign an informed consent document.
Q: What if I have had previous surgery?
A: Previous surgery does not generally exclude you from the study; however some types of previous spinal surgery may exclude a patient from the study.
Q: What are the risks of participating in this study?
A: There are known and unknown risks associated with any clinical trial. Such risks may include serious or life-threatening side effects as a result of the treatment. Possible risks are detailed and included in the informed consent document.
Q: How much does it cost to participate?
A: If a patient chooses to participate in the study, they do not typically incur more costs than they would if they choose not to participate in the study and instead receive the medical treatment that is the current standard of care. The Sponsor of the clinical trial will pay for the cost of any study-required examinations that differ from those normally required for non-investigational surgical procedures.
TRIUMPH®: Additional Information
Biomechanical Evaluation of a Posterolateral Lumbar Disc Arthroplasty Device. Kikkawa
et al. SPINE. Volume 35, Number 19, pp 1760-1768. Lippincott Williams & Wilkins, 2010.
Further information on the Clinical Trial can be found on www.clinicaltrials.gov.