This project will investigate the feasibility and the development of an implantable, compliant spine joint fixation prosthesis. The implant, different from existing rigid spine fixation devices which completely immobilize an unstable joint (for joint fusion and/or healing of fractured bone), will be designed to protect the spinal cord and nerve roots. The implant will protect the spinal cord by assisting the joint and intervertebral disc in supporting and distributing loads, while allowing for limited motion between vertebrae and surrounding joints. Phase I of research will be directed at the completion and verification of a compliant carbon fiber composite implant via bench tests and human cadaver studies. We are jointly pursuing the development of intraoperative instrumentation for quantitative assessment of spine joint instability pre and post decompressive surgery (a Spinal Stiffness Gauge [SSG]); the SSG is undergoing a clinical study at the University of Miami. The company's goal is that of a Spinal System employing both a means for diagnosing instability [SSG] and a means for treatment of instability with a compliant implant. An implant, required for any one spine joint, would be a function of the SSG stiffness measurement of the joint in compression, tension, and torsional tests. During Phase 11, an animal model (baboon) study will be completed and a multi-centered clinical study initiated to prove safety and efficacy of the treatment.Awardee's statement of the potential commercial applications of the research: The number of patients undergoing decompressive surgery in the U. S. A. is approximately 300,000; roughly 25% of these patients are instrumented with a rigid fixation system. An estimated 65 percent of the 300,000 patients undergoing decompressive surgery would benefit from the proposed compliant fixation prosthesis. Expected sales for Mekanika is 30 million dollars per year by 1996.National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
