title: Lumbar total disc replacement using ProDisc II: a prospective study with a 2-year minimum follow-up.
abstract: A lumbar total disc replacement (TDR) is believed to be a promising substitute in the surgical treatment for lumbar degenerative disc disease. The purpose of this study is to report the clinical and radiographic outcomes of 36 consecutive patients who underwent lumbar TDR using ProDisc II, and the factors associated with a better clinical outcome after a 2-year minimum follow-up. At the time of the latest follow-up, the success rate was 94% of 36 patients according to the criteria of the US Food and Drug Administration. Of the 10 patients unable to work preoperatively, 7 patients returned to work. Moreover, mean score on the visual analog scale for low back and leg pain improved significantly from 7.5 and 4.7 to 3.0 and 1.2, respectively (P<0.001). In addition, mean Oswestry disability index scores improved significantly from 69.2 to 21.0 (P<0.001). Mean disc height at the operative level increased significantly from 9.0 to 17.6 mm, and mean range of motion increased significantly from 9.7 to 12.7 degrees (P<0.01). Statistical analysis showed that the factors associated with a better clinical outcome were single level, and a higher postoperative segmental ROM at the operative level. At a minimum follow-up of 2 years, the lumbar TDR using ProDisc II showed excellent clinical and radiographic outcomes without any significant complication. However, future efforts need to be directed toward the evaluation of a larger number of patients with longer follow-up.
authors.affiliation: Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Kangnam-Gu, Seoul, Korea.
authors.forename: Sung Soo
authors.initials: SS
authors.lastname: Chung
authors.forename: Chong Suh
authors.initials: CS
authors.lastname: Lee
authors.forename: Chang Seok
authors.initials: CS
authors.lastname: Kang
mesh_terms: D000328:Adult; D001416:Back Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000175:diagnosis* / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D016059:Range of Motion, Articular; D020127:Recovery of Function; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome