Home » A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of Prodisc Total Disc
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of Prodisc Total Disc
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of Prodisc Total Disc Replacement to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated with Degenerative Disc Disease (DDD) in the Lumbosacral Spine
Approval Date: 2/11/2003
Principal Investigator: Harry N. Herkowitz, M.D.
This clinical trial is sponsored by Synthes Spine. The back is made up of donut-shaped bones called vertebrae that are stacked one on top of the other. Each vertebra is joined to and kept apart from its neighbor by a thick ring of rubbery tissue with a jelly like center, called a disc. These discs allow the spine to bend and twist and also serve as shock absorbers. An unhealthy or injured disc can cause severe back and/or leg pain. The surgeon has decided that this is the main cause of pain. The current standard surgical procedure for treating this condition is called fusion. In fusion surgery, the diseased disc is generally removed and the vertebrae on either side of the removed disc are joined with a bridge of bone so that they become one big bone and do not move relative to each other. The surgeon may refer to this as one level being fused. Fusion surgery requires surgically approaching the vertebrae through the lower abdomen (anterior approach), or through the back (posterior approach). Generally bone is taken from another part of the patient’s own body (such as the hip) and/or from a bone bank and surgically implanted in place of the diseased disc. Bone may also be laid across the back of the vertebrae to create a bridge across them. Metal screws and rods (known as pedicle screws) may also be implanted to hold the fusion in place during healing. Healing of the fusion may take 6 months or more. In the investigational procedure, the Prodisc will be implanted from the front (through the lower abdomen) in place of the diseased disc. The Prodisc is designed to mimic the normal disc and, thus, allow motion to continue between the vertebrae on either side of the disc. Although no man made replacement can do exactly what the natural disc does, the Prodisc may allow much of the normal motion to occur. The device is made up of two metal plates and a plastic piece (insert) that fits between the plates. The insert is flat on the bottom and round on top and snaps into the bottom metal plate. The top metal plate has a round dimple that sits on top of the round plastic insert. The top plate can therefore roll over the round plastic and move in relation to the bottom plate. The Prodisc is inserted in place of the diseased disc. The bottom plate rests on the top of the bottom vertebrae and the top plate rests on the bottom of the top vertebrae. Therefore, unlike fusion, which stops motion at the location of the diseased disc, the Prodisc replaces the diseased disc and is intended to allow motion. The metal and plastic used in the Prodisc are commonly used in other medical implants including hip and knee joint replacements. The metal plates are made from a cobalt chromium molybdenum mix (alloy), which is partially coated with titanium. The insert is made from polyethylene (ultrahigh molecular weight). In summary, the main purpose of both of the investigational procedure (Prodisc) and the current surgical treatment standard (fusion) is to reduce the pain and disability caused by the diseased disc. The fusion surgery tries to do it by removing the diseased disc and joining the neighboring vertebrae to prevent motion, whereas, the Prodisc implantation surgery tries to do it by removing the diseased disc and replacing it with a device that may allow continued motion of the neighboring vertebrae.
Eligibility:
" Each study has its own guidelines for who can participate, called "eligibility criteria". Below is a list of criteria for acceptance into the research study. Only the study doctor can make the determination that you meet all eligibility criteria."
Contact Person:
Gloria Kopper, RN, MSA, CCRC
248-551-7901
Status of Clinical Trial:
open and not enrolling
