A UCLA researcher seeks patients with degenerative disc disease to participate in a two-year clinical trial using an experimental spinal implant device to fuse -- connect with bone -- the vertebrae versus taking a bone graft from the patient's hip. Subjects will be randomly assigned to one of two groups: experimental device or standard treatment (control group).
The experimental spinal implant device consists of three components: recombinant human bone morphogenetic protein-2 (rhBMP-2), compression-resistant matrix (CRM) and the CD HORIZON Spinal System. The process works by taking the rhBMP-2, which is manufactured bone-growing protein, and soaking it into the CRM -- a sponge-like material. The CRM soaked with rhBMP-2 is placed between two vertebrae, replacing the degenerative disc. While bone grows and fuses the vertebrae together, the CD HORIZON Spinal System is used to temporarily stabilize the spine with titanium alloy rods.
The clinical trial will evaluate the effectiveness of rhBMP-2 to treat degenerative disc disease in the lower back when used with the CRM and the CD HORIZON Spinal System compared to the standard treatment of taking bone from a patient's hip and using the CD HORIZON Spinal System. Participants will have a 50/50 chance of being placed in either group.
Prior to surgery, subjects will have x-rays, MRI and/or CT scans performed to evaluate the degenerative disc problem. A DEXA scan may be done to determine bone density in patients with risk factors for osteoporosis. Subjects undergoing the experimental procedure will need to give blood samples to test for the presence of antibodies to rhBMP-2. All participants will be followed for a minimum of two years with follow-up office visits required at 6 weeks, and at 3, 6, 12 and 24 months post surgery.
Medtronic Sofamor Danek, the company that makes the implant device, is sponsoring the study and will pay for the rhBMP-2 substance. Patients are responsible for the actual surgery. Patients will be compensated $100 at the one-year visit and $200 at the two-year visit regardless of any reported side effects or other illnesses.
For evaluation to participate in the study, call (310) 206-8263.
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