title: Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.
abstract: METHODS
  A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.
  
  
  OBJECTIVE
  To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1.
  
  
  BACKGROUND
  As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously.
  
  
  METHODS
  Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation.
  
  
  RESULTS
  Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees.
  
  
  CONCLUSIONS
  ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.
authors.affiliation: Texas Back Institute/Texas Health Research Institute, Plano, TX 75093, USA. jzigler@texasback.com
authors.forename: Jack
authors.initials: J
authors.lastname: Zigler
authors.forename: Rick
authors.initials: R
authors.lastname: Delamarter
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Spivak
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Linovitz
authors.forename: Guy O
authors.initials: GO
authors.lastname: Danielson
authors.forename: Thomas T
authors.initials: TT
authors.lastname: Haider
authors.forename: Frank
authors.initials: F
authors.lastname: Cammisa
authors.forename: Jim
authors.initials: J
authors.lastname: Zuchermann
authors.forename: Richard
authors.initials: R
authors.lastname: Balderston
authors.forename: Scott
authors.initials: S
authors.lastname: Kitchel
authors.forename: Kevin
authors.initials: K
authors.lastname: Foley
authors.forename: Robert
authors.initials: R
authors.lastname: Watkins
authors.forename: David
authors.initials: D
authors.lastname: Bradford
authors.forename: James
authors.initials: J
authors.lastname: Yue
authors.forename: Hansen
authors.initials: H
authors.lastname: Yuan
authors.forename: Harry
authors.initials: H
authors.lastname: Herkowitz
authors.forename: Doug
authors.initials: D
authors.lastname: Geiger
authors.forename: John
authors.initials: J
authors.lastname: Bendo
authors.forename: Timothy
authors.initials: T
authors.lastname: Peppers
authors.forename: Barton
authors.initials: B
authors.lastname: Sachs
authors.forename: Federico
authors.initials: F
authors.lastname: Girardi
authors.forename: Michael
authors.initials: M
authors.lastname: Kropf
authors.forename: Jeff
authors.initials: J
authors.lastname: Goldstein
mesh_terms: D000328:Adult; D019643:Arthroplasty, Replacement / Q000009:adverse effects / Q000295:instrumentation*; D018795:Device Approval; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D017116:Low Back Pain / Q000188:drug therapy / Q000209:etiology* / Q000601:surgery; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D009294:Narcotics / Q000627:therapeutic use; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D016059:Range of Motion, Articular; D020127:Recovery of Function; D013122:Spinal Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D013123:Spinal Fusion; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D009294:Narcotics