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

Jack Zigler, Rick Delamarter, Jeffrey M. Spivak, Raymond J. Linovitz, Guy O. Danielson, Thomas T. Haider, Frank Cammisa, Jim Zuchermann, Richard Balderston, Scott Kitchel, Kevin Foley, Robert Watkins, David Bradford, James Yue, Hansen Yuan, Harry Herkowitz, Doug Geiger, John Bendo, Timothy Peppers, Barton Sachs & 3 others Federico Girardi, Michael Kropf, Jeff Goldstein

Research output: Contribution to journalArticle

313 Citations (Scopus)

Abstract

STUDY DESIGN. 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. SUMMARY OF BACKGROUND DATA. 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 ≥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°. 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.

Original languageEnglish (US)
Pages (from-to)1155-1162
Number of pages8
JournalSpine
Volume32
Issue number11
DOIs
StatePublished - May 1 2007

Fingerprint

Total Disc Replacement
United States Food and Drug Administration
Equipment and Supplies
Therapeutics
Visual Analog Scale
Control Groups
Clinical Trials
Safety
Spinal Fusion
Neurologic Examination
Pain Measurement
Articular Range of Motion
Low Back Pain
Health Surveys
Patient Satisfaction
Nervous System
Physical Examination
Reference Values
Spine

All Science Journal Classification (ASJC) codes

  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

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. / Zigler, Jack; Delamarter, Rick; Spivak, Jeffrey M.; Linovitz, Raymond J.; Danielson, Guy O.; Haider, Thomas T.; Cammisa, Frank; Zuchermann, Jim; Balderston, Richard; Kitchel, Scott; Foley, Kevin; Watkins, Robert; Bradford, David; Yue, James; Yuan, Hansen; Herkowitz, Harry; Geiger, Doug; Bendo, John; Peppers, Timothy; Sachs, Barton; Girardi, Federico; Kropf, Michael; Goldstein, Jeff.

In: Spine, Vol. 32, No. 11, 01.05.2007, p. 1155-1162.

Research output: Contribution to journalArticle

Zigler, J, Delamarter, R, Spivak, JM, Linovitz, RJ, Danielson, GO, Haider, TT, Cammisa, F, Zuchermann, J, Balderston, R, Kitchel, S, Foley, K, Watkins, R, Bradford, D, Yue, J, Yuan, H, Herkowitz, H, Geiger, D, Bendo, J, Peppers, T, Sachs, B, Girardi, F, Kropf, M & Goldstein, J 2007, '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', Spine, vol. 32, no. 11, pp. 1155-1162. https://doi.org/10.1097/BRS.0b013e318054e377
Zigler, Jack ; Delamarter, Rick ; Spivak, Jeffrey M. ; Linovitz, Raymond J. ; Danielson, Guy O. ; Haider, Thomas T. ; Cammisa, Frank ; Zuchermann, Jim ; Balderston, Richard ; Kitchel, Scott ; Foley, Kevin ; Watkins, Robert ; Bradford, David ; Yue, James ; Yuan, Hansen ; Herkowitz, Harry ; Geiger, Doug ; Bendo, John ; Peppers, Timothy ; Sachs, Barton ; Girardi, Federico ; Kropf, Michael ; Goldstein, Jeff. / 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. In: Spine. 2007 ; Vol. 32, No. 11. pp. 1155-1162.
@article{2a28eedb1d024bc1b81f6235df86dc57,
title = "Results of the prospective, randomized, multicenter food and drug administration investigational device exemption study of the ProDisc{\circledR}-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease",
abstract = "STUDY DESIGN. A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVE. To evaluate the safety and effectiveness of the ProDisc{\circledR}-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. SUMMARY OF BACKGROUND DATA. As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc{\circledR}-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{\circledR}-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 ≥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{\circledR}-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°. CONCLUSIONS. ProDisc{\circledR}-L has been found to be safe and efficacious. In properly chosen patients, ProDisc{\circledR}-L has been shown to be superior to circumferential fusion by multiple clinical criteria.",
author = "Jack Zigler and Rick Delamarter and Spivak, {Jeffrey M.} and Linovitz, {Raymond J.} and Danielson, {Guy O.} and Haider, {Thomas T.} and Frank Cammisa and Jim Zuchermann and Richard Balderston and Scott Kitchel and Kevin Foley and Robert Watkins and David Bradford and James Yue and Hansen Yuan and Harry Herkowitz and Doug Geiger and John Bendo and Timothy Peppers and Barton Sachs and Federico Girardi and Michael Kropf and Jeff Goldstein",
year = "2007",
month = "5",
day = "1",
doi = "10.1097/BRS.0b013e318054e377",
language = "English (US)",
volume = "32",
pages = "1155--1162",
journal = "Spine",
issn = "0362-2436",
publisher = "Lippincott Williams and Wilkins",
number = "11",

}

TY - JOUR

T1 - 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

AU - Zigler, Jack

AU - Delamarter, Rick

AU - Spivak, Jeffrey M.

AU - Linovitz, Raymond J.

AU - Danielson, Guy O.

AU - Haider, Thomas T.

AU - Cammisa, Frank

AU - Zuchermann, Jim

AU - Balderston, Richard

AU - Kitchel, Scott

AU - Foley, Kevin

AU - Watkins, Robert

AU - Bradford, David

AU - Yue, James

AU - Yuan, Hansen

AU - Herkowitz, Harry

AU - Geiger, Doug

AU - Bendo, John

AU - Peppers, Timothy

AU - Sachs, Barton

AU - Girardi, Federico

AU - Kropf, Michael

AU - Goldstein, Jeff

PY - 2007/5/1

Y1 - 2007/5/1

N2 - STUDY DESIGN. 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. SUMMARY OF BACKGROUND DATA. 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 ≥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°. 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.

AB - STUDY DESIGN. 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. SUMMARY OF BACKGROUND DATA. 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 ≥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°. 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.

UR - http://www.scopus.com/inward/record.url?scp=34248399204&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34248399204&partnerID=8YFLogxK

U2 - 10.1097/BRS.0b013e318054e377

DO - 10.1097/BRS.0b013e318054e377

M3 - Article

VL - 32

SP - 1155

EP - 1162

JO - Spine

JF - Spine

SN - 0362-2436

IS - 11

ER -