ACADIA® Facet Replacement System
The ACADIA® Facet Replacement System is a bilateral implant system designed to restore and mimic the facet joints in the lumbar spine. ACADIA® is manufactured from cobalt chrome alloy with highly polished articulating surfaces. Portions of the implant is coated with hydroxyapetite to promote bony on growth. The implant is secured to the bone with pedicle screws fastened with locking nuts. A crosslink offers added coupled and rotational support. ACADIA® is available in an assortment of sizes to fit patient anatomy.
CAUTION: Investigational Device. Limited by Federal (U.S.) Law to Investigational use.
The ACADIA® Facet Replacement System is indicated for patients who have degenerative lateral, lateral recess and/or central canal stenosis at a single level from L3 to S1 that require decompression and facetectomy and have failed to improve with at least six cumulative months of conservative treatment. Adjacent lumbar vertebrae levels may also be treated through decompression, as required to treat stenosis, which does not result in complete facetectomy or fusion.
Historically, degeneration and instability of the facet joint and associated stenosis has been addressed surgically through decompression, facetectomy and posterior fusion. Although these treatments may alleviate pain, they may result in further destabilization or in the case of fusion, loss of motion. It has also been theorized that fusion transfers stresses to the adjacent motion segments creating additional degeneration and instability in these adjacent segments. The ACADIA® Facet Replacement System was invented to provide an alternative to the current practice of posterior fusion. ACADIA® is designed to allow motion while restoring stability after decompression and removal of degenerated facets.
IDE Clinical Trial
The U.S. Food and Drug Administration has determined that the ACADIA® Facet Replacement System is an investigational device in the United States. Globus Medical is sponsoring a Clinical Trial under an Investigational Device Exemption (IDE) to evaluate the ACADIA® Facet Replacement System for the treatment of degenerative lateral, lateral recess and/or central canal stenosis at a single level from L3 to S1 that requires a lumbar decompression and facetectomy compared to an instrumented posterolateral fusion. Patients who enroll in the study must be between the ages of 21 and 85, have degenerative lumbar spinal stenosis at one spinal level from L3 to S1; have had at least six cumulative months of conservative treatment; have leg, thigh, and/or buttock symptoms; are able to attend all follow-up exams; and meet further eligibility criteria.
The ACADIA® Facet Replacement System is implanted through a posterior midline incision. The neural elements are decompressed and pedicle screws and bases are inserted. ACADIA® instruments facilitate placement of the inferior and superior articulating facet replacement implants. The cobalt chrome articulating components are aligned and secured at their natural anatomical position on the pedicle. A crosslink completes the construct, providing additional support and stability. After surgery, ACADIA® is designed to move and slide to allow motion in the spinal segment.
Frequently Asked Questions
Q: What is the purpose of the study?
A: The purpose of the ACADIA® IDE clinical trial is to determine if the ACADIA® Facet Replacement System is safe and effective for treating degenerative lumbar spinal stenosis.
Q: How is the ACADIA® Facet Replacement System different from an instrumented posterolateral spinal fusion?
A: The primary difference between ACADIA® and a posterolateral fusion is that the ACADIA® Facet Replacement System is designed to allow motion while restoring stability after decompression and facetectomy. Posterolateral fusion is designed to prevent motion at a spinal segment by permanently fusing two or more vertebrae together. A fusion procedure may help to alleviate painful symptoms but has potential disadvantages, including loss of motion. Stresses may be transferred to spinal segments above and below the fused segment, possibly creating additional degeneration and instability in these adjacent segments.
Q: Are most spine surgeons familiar with a posterior surgical approach to the spine?
A: The posterior surgical approach to the spine is used to implant ACADIA®. Most spine surgeons should be familiar with a posterior surgical approach to the spine. The techniques used to access and decompress the spine to relieve pressure are very similar, whether the surgeon is implanting ACADIA® or fusing the segment. However, every surgeon’s level of expertise in a given condition can vary based on their individual education and the patient population they treat. Surgeons who participate in this clinical trial are trained in the proper implantation technique for ACADIA®and are experienced in the posterior approach to the lumbar spine.
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: Participation in the study does not usually require any additional costs to the current standard treatment of care. The Sponsor of the clinical trial, Globus Medical, will pay for the cost of any study-required examinations that differ from those normally required for non-investigational surgical procedures.
Further information on the ACADIA® IDE clinical trial can be found on www.clinicaltrials.gov