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.
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.
Zigler
Jack
J
Texas Back Institute/Texas Health Research Institute, Plano, TX 75093, USA. jzigler@texasback.com
Delamarter
Rick
R
Spivak
Jeffrey M
JM
Linovitz
Raymond J
RJ
Danielson
Guy O
GO
Haider
Thomas T
TT
Cammisa
Frank
F
Zuchermann
Jim
J
Balderston
Richard
R
Kitchel
Scott
S
Foley
Kevin
K
Watkins
Robert
R
Bradford
David
D
Yue
James
J
Yuan
Hansen
H
Herkowitz
Harry
H
Geiger
Doug
D
Bendo
John
J
Peppers
Timothy
T
Sachs
Barton
B
Girardi
Federico
F
Kropf
Michael
M
Goldstein
Jeff
J
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
D009294:Narcotics