Cervical Disc Replacement clinical trials available at the Spine Institute.
The Spine Institute of New York is one of the select centers participating in a national clinical investigation of cervical artificial disc replacement surgery. The procedure is targeted for the treatment of cervical disc disease, resulting from disc degeneration or injury to the cervical vertebrae – or bones of the neck.
Cervical disc disease occurs when the gel-like discs between the vertebrae of the neck become dislodged due to accidents, muscle strain, arthritis or aging. The condition may impinge on the spinal cord or nerves, often resulting in neck pain, radiating arm pain and temporary changes in nerve function that may cause tingling, lack of coordination, numbness or weakness in an arm or hand.
Cervical disc replacement surgery would most typically be done for patients with cervical disc herniations that have not responded to non-surgical treatment options and are significantly affecting the individuals’ quality of life and ability to function.
Cervical Artificial Disc Replacement is a new surgical technique that may be done instead of an anterior cervical discectomy and fusion. In cervical artificial disc replacement surgery, a small prosthetic device is inserted into the vertebrae to replace the removed disc. This investigational device is designed to provide the motion and elastic characteristics of the natural cervical disc.
Please contact our study coordinator to find out if you are a good candidate for the cervical disc replacement.
Study Coordinator: Dr. Ketevan K. Berekashvili
Phone: (212) 844-6900
Disc replacement surgery is an appropriate treatment option for patients with degenerative disc disease who have ongoing lower back pain that does not respond to conservative treatments. In this procedure, a surgeon replaces the diseased disc with a synthetic one. This alleviates pain by relieving the pressure the diseased disc was exerting on the nerve. Disc replacement surgery, however, is not currently a viable treatment option for all degenerative disc disease patients. The procedure is currently limited to patients with single level disease. For those that are eligible, total disc replacement offers mechanical stability, restored mobility to the spine, and significant pain relief.
Disc replacement, pioneered in France and Germany, has been performed in Europe for the past two decades. In the US, the FDA’s Orthopedic and Rehabilitation Devices Panel just recently recommended the use of total disc replacement utilizing Link SB Charité Intervertebral Prosthesis, an artificial disc, to treat degenerative disc disease. To date, 7,000 patients have been successfully treated with the CHARITÉ Artificial Disc, which is available in more than 30 countries throughout the world.
The CHARITÉ Artificial Disc is made of two metal endplates and a polyethylene core that allows for motion and function very much like a normal disc. The Charité Artificial Disc was designed to restore disc space height, to restore motion segment flexibility, to prevent disc degeneration at adjacent segments, to reduce or eliminate pain from motion or from nerve compression, and to improve the patient’s functional activities. It was designed to be biocompatible and durable. It has a life span of 40 years (85 million cycles).
The surgical approach is typically through an anterior retro-peritoneal route. Patient positioning is important so that radiographic confirmation of the implant position can be seen easily by the surgical team. Factors critical for a good result using the Charité are proper patient selection, selecting the correct prosthesis size, and proper prosthesis positioning with the CentreLine Instruments.
Lumbar spinal fusion surgery using metal implants, bone or fusion cages is performed to treat a degenerated disc. This procedure helps reduce back pain, but limits a patient’s range of motion and may unnaturally stress adjacent anatomy. Spinal fusion is performed on more than 200,000 people each year in the United States. The CHARITÉ Artificial Disc is intended to provide an alternative to lumbar spinal fusion surgery.
Chronic back and leg pain in the lumbar region, caused by problems with the intervertebral discs, are usually treated non-invasively for as long as possible. When such treatment no longer provides relief, the primary solution until now has included removal of the affected discs and fusion of the vertebral segments. It is estimated that nearly 400,000 people in the U.S. undergo spinal fusion procedures each year.
The first Dynesys device was implanted in Europe in 1994 and has treated over 9,000 patients. The Dynesys Spinal System has recently been approved for clinical trials at only 20 spine centers in the United States, including the Spine Institute of New York. This procedure may provide an alternative to patients suffering from spondylolisthesis and spinal stenosis, who previously would have needed spinal fusion surgery to moderate pain from compressed nerves.
The Spine Institute is one of the twenty hospitals enrolling patients into this FDA controlled clinical trial to assess the safety and effectiveness of the Dynesys Spinal System. This new treatment will be compared to the current standard treatment to see which is more successful.
The Dynesys system consists of external spacers made of surgical polyurethane (flexible plastic tubing) surrounding a polyethylene (nylon-like) cord. The device is attached to both sides of the vertebrae in the affected area of the spine, stabilizing the spine without fusing and preserving its natural curve, which allows the patient a greater degree of mobility, in addition to reducing the pain caused by excess motion.
Many people, due to religious or personal convictions, object to receiving blood or blood products during medical treatment. “Bloodless Surgery” is a new procedure that incorporates several techniques and steps to help your body compensate for blood loss before, during and after surgery, without the use of donor blood. Also, the use of pharmaceutical agents, intravenous fluids, and improved diagnostic procedures and surgical techniques can prevent or lessen the anemia associated with surgery and other medical procedures.
Several methods can be used in bloodless surgery with careful planning and state of the art techniques. Some of these methods are:
- Recombinant human erythropoietin, a synthetic hormone used to stimulate the bone marrow to produce more red blood cells.
- Preoperative autologous donation, an option for selected patients who wish to donate their own blood prior to certain elective surgeries
- Intraoperative surgical techniques and instruments (eg, ultrasound, gamma knife, argon beam) are available that can improve hemostasis. The use of these instruments, along with minimally invasive surgical approaches (eg, laparoscopy, endoscopy, interventional radiological procedures) can reduce surgical blood loss dramatically.
- Intraoperative hemodilution is the practice of withdrawing whole blood from patients before surgical blood loss and simultaneously replacing the withdrawn autologous blood with intravenous fluids. The whole fresh blood is kept in the OR in storage bags. After surgical bleeding has ended, the whole blood, complete with all coagulation factors functioning, is retransfused to patients.
- Biological products like collagen and cellulose woven pads stop bleeding by direct application
- Perioperative blood salvage includes the cell saver that recovers and recycles blood lost during surgery by collecting, cleaning, and returning blood to the patient.
Reduces danger of infection and immune suppression May allow for a shorter recovery time and quicker discharges Prevents cancellations or postponement of surgeries due to blood shortages Avoids costs associated with laboratory errors in blood typing.
Back surgery potentially involves significant blood loss. The Spine Center of New York is part of the New York Center for Bloodless Medicine and Surgery, which is dedicated to providing high quality health care without the use of donor blood or blood products, for patients who chose to do so during their medical treatment. We offer vast experience in protocols that enable patients to undergo surgery without blood transfusions.
The Spine Institute uses this procedure in treating a large Jehovah Witness population – the world headquarters for Jehovah Witnesses -in the Brooklyn area. The Bloodless surgery incorporates techniques that include both nerve sparring and minimal blood losses.
For more information please call The New York Center For Bloodless Medicine and Surgery at 1-888-299-6625.
So what makes a good bone graft? All bone grafts are judged on three elements: osteoconductive scaffolding, osteoinductive growth factors, and the ability to incorporate with osteogenetic progenitor cells found in the human body. Though the terms may be difficult, the concept is relatively simple. These elements have been successfully achieved by the use of a particular graft taken from a patient’s own body.
Currently there is only one bone graft available that has been proven to meet all three elements. rhBMP2, or INFUSE® Bone Graft not only utilizes an osteoconductive scaffold, contains an effective level of BMP to be osteoinductive and initiates the process of bone formation, but also does not require any second procedures. INFUSE® Bone Graft does not need autograft or bone marrow aspirate.
The use of rhBMP-2 is still in an experimental stage. Spine surgeons have recently integrated INFUSE into their surgical repertoire as a surgical treatment option for patients suffering from degenerative disc disease.
The Spine Institute is currently engaged in the randomized clinical research study of the spinal implant device which consists of three components: (1) recombinant human bone morphogenetic protein-2 (rhBMP-2) which is soaked into (2) compression resistant matrix (CRM) and used with (3) the CD HORIZON® Spinal System. BMP-2 is a human protein.
Bone Morphogenetic Protein – 2, (BMP – 2), is a specific protein that has been clinically proven to stimulate bone growth. BMP-2 is found in trace amounts in human bone, but the limited supply of human donor bones precludes its extraction as an option. To solve this problem of finite supply, a recombinant version of naturally occurring BMP – 2 is manufactured using molecular biology techniques. The result is Recombinant Human Bone Morphogenetic Protein – 2, or rhBMP – 2.
Instead of using bone harvested from other parts of the patient’s body to generate bone growth in the spine, doctors insert rhBMP-2 between two or more vertebrae. This insertion induces bone growth and causes the vertebrae to fuse together, re-establishing spinal stability and alleviating pain caused by pressure on the nerves.
The “gold standard” of all bone grafts, has been a graft surgically removed from the iliac crest (hip area) of the patient about to have spinal fusion surgery. This bone graft is called an “autograft.” The problem with an autograft, is the procedure needed to access the bone and remove it, can cause complications of its own. Studies show an increased operative time, increased patient recovery time, and chronic pain at the location where the bone graft was taken as common complications of this procedure. Also, not everyone has bone suitable for use during surgery. A patient suffering from osteoporosis or who smokes is typically not a good candidate for autograft fusions. Because of these problems with autograft many physicians and researchers have tried to find or manufacture options that hold up to the high standards of autograft, without the complications.
Bone Marrow Aspirate
The problems and complications that occur when using bone marrow aspirate are similar to those that occur with autograft taken from the iliac crest. According to the National Institutes of Health, most patients complain of pain during this procedure. Besides pain, bleeding is the most common complication, and bruising at the donor site can also occur. According to the May 2002 supplement of Orthopedics, no human studies have currently been performed to test the osteoinductive properties of bone marrow aspirate.