Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: Five-year follow-up

• Published in: The spine journal Vol. 9; no. 5; pp. 374 - 386
• Main Authors: Guyer, Richard D., McAfee, Paul C., Banco, Robert J., Bitan, Fabian D., Cappuccino, Andrew, Geisler, Fred H., Hochschuler, Stephen H., Holt, Richard T., Jenis, Louis G., Majd, Mohamed E., Regan, John J., Tromanhauser, Scott G., Wong, Douglas C., Blumenthal, Scott L.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2009
• Subjects: 5-year follow-up; Adult; Arthrodesis; Arthroplasty; Arthroplasty, Replacement - adverse effects; Arthroplasty, Replacement - instrumentation; Arthroplasty, Replacement - methods; Equipment Failure; Female; Follow-Up Studies; Humans; Intervertebral Disc - surgery; Intervertebral Disc Displacement - surgery; Joint Prosthesis - adverse effects; Lumbar Vertebrae; Male; Middle Aged; Orthopedics; Pain Measurement; Randomized controled trial; Range of Motion, Articular; Recovery of Function; Spinal Fusion - adverse effects; Spinal Fusion - instrumentation; Spinal Fusion - methods; Treatment Outcome; United States; United States Food and Drug Administration; United States; Arthrodesis; 5-year follow-up; Arthroplasty; Randomized controled trial

The CHARITÉ artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized,...