Wise Young
10-01-2001, 10:28 PM
DISC REPLACEMENT SURGERY
The SB Charite III Intervertebral
Dynamic Disc Spacer FDA Study
The surgical procedure for the SB Charite places an implant using the anterior (front) approach. The disc is removed at the effected level and the SB Charite device placed into the space.
The SB Charite disc replacement method is an experimental type of surgery in the United States. The Food and Drug Administration (FDA) considers the SB Charite implant an "Investigational Device."
The FDA is allowing a small number of selected doctors to use the SB Charite on a specific number of patients. Each patient selected is checked by the doctor at specific times for at least two (2) years to monitor each patient's progress. This is called a "Clinical Investigation". When all the patient results are given to the FDA, they will decide if the SB Charite may be used for the general public. THIS IS A RANDOMIZED STUDY. SIXTY-SEVEN PERCENT (67%) OF THE PATIENTS RECEIVE THE ARTIFICIAL DISC IMPLANT AND 33% RECEIVE THE BAK FUSION. The patient does not know which implant they will receive until AFTER the surgery.
INCLUSION CRITERIA
* Age between 18 and 60 years
* Diagnosis of Degenerative Disc Disease at the L4/L5 or L5/S1 level
* At least six months of conservative treatment
EXCLUSION CRITERIA
* Previous back surgery (except discectomy, laminotomy or nucleolysis at the same level) or other spinal surgery at any level
* Multiple levels of degeneration
* Osteoporosis, osteopenia or other metabolic bone disease
* Spondylolisthesis, scoliosis or spinal tumor
* History of chronic steroid use
* Pregnancy
* Autoimmune disorder
* Morbid obesity
* Medicare/Medicaid insurance coverage
FOR FURTHER INFORMATION ABOUT THE ARTIFICIAL DISC REPLACEMENT STUDY, CONTACT Nanette Dietmeyer, Research Coordinator, at (502) 585-2300 or ndietmeyer@spine-surgery.com
15 Study Sites
Texas Back Institute, 6300 West Parker Road, Plano, Texas 75093 (972) 981-3746
Scoliosis and Spine Center, 7505 Osler Drive Suite 104, Towson, Maryland 21204, (410) 337-8888
Spine Surgery, PSC, 210 East Gray Street Suite 601, Louisville, Kentucky 40202, (502) 585-2300, Nanette Dietmeyer, Study Coordinator
Orthopedic Care & Sports Medicine Center, 21000 North East 28 Avenue Suite 104, Aventura, Florida, 33180, (305) 937-1999
Louisiana Orthopedic Institute, 16777 Medical Center Drive Suite 300, Baton Rouge, Louisiana, 70816, (225) 751-6666
Panorama Orthopedic Clinic, 660 Golden Ridge Road, Suite 250, Golden, Colorado 80401, (303) 233-1223
Mount Carmel East Hospital, 6001 East Broad Street, Columbus, Ohio 43213 (614) 868-5872
The Bone & Joint Clinic, 206 Bedford Way, Franklin, Tennessee 37064 (615) 790-3290
Scottsdale Spine Center, 7301 East 2nd Street Suite 118, Scottsdale, Arizona 85251 (480) 990-8011
Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Suite 5P, New York, New York 10003 (212) 844-8669
Northtowns Orthopedics, 46 Davison Court, Lockport, New York 14094 (716) 438-2976
Chicago Institute Neurosurgery & Neuroresearch (CINN), 2515 North Clark Street Suite 800, Chicago, Illinois 60614 (773) 388-7706
G & P Orthopedic Associates, 120 South Spalding Drive Suite 400, Beverly Hills, California 90212 (310) 860-3450
USC University Hospital, Center for Orthopedic Spinal Surgery, 1500 San Pablo Street, 7 North, Los Angeles, California 90033 (323) 442-5300
Boston Spine Group, 125 Park Hill Avenue, Boston, Massachusetts 02120 (617) 754-6360
European Medical Centers using the Artificial Disc device:
Thierry David, MD
The Department of Orthopaedics
Polyclinique De Bois Bernard
Rouvroy, France
Prof. Dr. A. Benini
Spine Unit Schulthess Klinik
Lengghalde 2
Ch 8008 Zurich, Switzerland
Dr. med. Karin Buttner-Janz
Klinik und Poliklinik fur
Orthopadie des Bereichs Medizin (Charite) der Humboldt-Universitat
Schumannstrasse 20/21
Berlin D-10117
J.P. Lemaire, MD
Centre d'Etude et de Chirurgie du Rachis
Point Medical
Rond Point de la Nation
21000 Dijon, France
L.M.L. J. Bohnen
Oude Rijksweg Noord 30
NL-6114 JE Susteren
The Netherlands
References:
Zeegers WS, Bohnen WMLJ, Laaper M, Verhaegen MJA: Artificial disc replacement with the modular type SB Charite' III: 2-year results in 50 prospectively studies patients. Eur Spine J (1999) 8:210-217.
Benini A: Indications for Single-Segment Intervertebral Prosthesis Implantation. Rivista di Neuroradiolgia. 12:Suppl 1 171-173, 1999.
Lemaire JP, Skalli W: Lavaste F, Templier A, Mendes F, Diop A, Sauty V and Laloux E: Intervertebral disc prosthesis: Results and prospects for the Year 2000. CORR, 337:64-76, 1997.
David TJ: Lumbosacral Disc Prostheses. Lumbosacral and Spinopelvic Fixation 881-887, 1996.
Cinotti G, David T and Postacchini F: Results of Disc Prosthesis after a minimum follow-up period of 2 years. SPINE 21:8, 995-1000, 1996.
Griffith SL, Shelokov AP, Buttner-Janz K, LeMaire JP, Zeegers WS: A Multicenter Retrospective Study of the Clinical Results of the Link SB Charite' Intervertebral Prosthesis. The Initial European Experience. Spine 19:16 1842-1849, 1994.
David T: Lumbar disc prosthesis. Surgical technique, indications and clinical results in 22 patients with a minimum of 12 months follow-up. Eur S J (1993) 1:254-259
The SB Charite III Intervertebral
Dynamic Disc Spacer FDA Study
The surgical procedure for the SB Charite places an implant using the anterior (front) approach. The disc is removed at the effected level and the SB Charite device placed into the space.
The SB Charite disc replacement method is an experimental type of surgery in the United States. The Food and Drug Administration (FDA) considers the SB Charite implant an "Investigational Device."
The FDA is allowing a small number of selected doctors to use the SB Charite on a specific number of patients. Each patient selected is checked by the doctor at specific times for at least two (2) years to monitor each patient's progress. This is called a "Clinical Investigation". When all the patient results are given to the FDA, they will decide if the SB Charite may be used for the general public. THIS IS A RANDOMIZED STUDY. SIXTY-SEVEN PERCENT (67%) OF THE PATIENTS RECEIVE THE ARTIFICIAL DISC IMPLANT AND 33% RECEIVE THE BAK FUSION. The patient does not know which implant they will receive until AFTER the surgery.
INCLUSION CRITERIA
* Age between 18 and 60 years
* Diagnosis of Degenerative Disc Disease at the L4/L5 or L5/S1 level
* At least six months of conservative treatment
EXCLUSION CRITERIA
* Previous back surgery (except discectomy, laminotomy or nucleolysis at the same level) or other spinal surgery at any level
* Multiple levels of degeneration
* Osteoporosis, osteopenia or other metabolic bone disease
* Spondylolisthesis, scoliosis or spinal tumor
* History of chronic steroid use
* Pregnancy
* Autoimmune disorder
* Morbid obesity
* Medicare/Medicaid insurance coverage
FOR FURTHER INFORMATION ABOUT THE ARTIFICIAL DISC REPLACEMENT STUDY, CONTACT Nanette Dietmeyer, Research Coordinator, at (502) 585-2300 or ndietmeyer@spine-surgery.com
15 Study Sites
Texas Back Institute, 6300 West Parker Road, Plano, Texas 75093 (972) 981-3746
Scoliosis and Spine Center, 7505 Osler Drive Suite 104, Towson, Maryland 21204, (410) 337-8888
Spine Surgery, PSC, 210 East Gray Street Suite 601, Louisville, Kentucky 40202, (502) 585-2300, Nanette Dietmeyer, Study Coordinator
Orthopedic Care & Sports Medicine Center, 21000 North East 28 Avenue Suite 104, Aventura, Florida, 33180, (305) 937-1999
Louisiana Orthopedic Institute, 16777 Medical Center Drive Suite 300, Baton Rouge, Louisiana, 70816, (225) 751-6666
Panorama Orthopedic Clinic, 660 Golden Ridge Road, Suite 250, Golden, Colorado 80401, (303) 233-1223
Mount Carmel East Hospital, 6001 East Broad Street, Columbus, Ohio 43213 (614) 868-5872
The Bone & Joint Clinic, 206 Bedford Way, Franklin, Tennessee 37064 (615) 790-3290
Scottsdale Spine Center, 7301 East 2nd Street Suite 118, Scottsdale, Arizona 85251 (480) 990-8011
Beth Israel Medical Center, Phillips Ambulatory Care Center, 10 Union Square East Suite 5P, New York, New York 10003 (212) 844-8669
Northtowns Orthopedics, 46 Davison Court, Lockport, New York 14094 (716) 438-2976
Chicago Institute Neurosurgery & Neuroresearch (CINN), 2515 North Clark Street Suite 800, Chicago, Illinois 60614 (773) 388-7706
G & P Orthopedic Associates, 120 South Spalding Drive Suite 400, Beverly Hills, California 90212 (310) 860-3450
USC University Hospital, Center for Orthopedic Spinal Surgery, 1500 San Pablo Street, 7 North, Los Angeles, California 90033 (323) 442-5300
Boston Spine Group, 125 Park Hill Avenue, Boston, Massachusetts 02120 (617) 754-6360
European Medical Centers using the Artificial Disc device:
Thierry David, MD
The Department of Orthopaedics
Polyclinique De Bois Bernard
Rouvroy, France
Prof. Dr. A. Benini
Spine Unit Schulthess Klinik
Lengghalde 2
Ch 8008 Zurich, Switzerland
Dr. med. Karin Buttner-Janz
Klinik und Poliklinik fur
Orthopadie des Bereichs Medizin (Charite) der Humboldt-Universitat
Schumannstrasse 20/21
Berlin D-10117
J.P. Lemaire, MD
Centre d'Etude et de Chirurgie du Rachis
Point Medical
Rond Point de la Nation
21000 Dijon, France
L.M.L. J. Bohnen
Oude Rijksweg Noord 30
NL-6114 JE Susteren
The Netherlands
References:
Zeegers WS, Bohnen WMLJ, Laaper M, Verhaegen MJA: Artificial disc replacement with the modular type SB Charite' III: 2-year results in 50 prospectively studies patients. Eur Spine J (1999) 8:210-217.
Benini A: Indications for Single-Segment Intervertebral Prosthesis Implantation. Rivista di Neuroradiolgia. 12:Suppl 1 171-173, 1999.
Lemaire JP, Skalli W: Lavaste F, Templier A, Mendes F, Diop A, Sauty V and Laloux E: Intervertebral disc prosthesis: Results and prospects for the Year 2000. CORR, 337:64-76, 1997.
David TJ: Lumbosacral Disc Prostheses. Lumbosacral and Spinopelvic Fixation 881-887, 1996.
Cinotti G, David T and Postacchini F: Results of Disc Prosthesis after a minimum follow-up period of 2 years. SPINE 21:8, 995-1000, 1996.
Griffith SL, Shelokov AP, Buttner-Janz K, LeMaire JP, Zeegers WS: A Multicenter Retrospective Study of the Clinical Results of the Link SB Charite' Intervertebral Prosthesis. The Initial European Experience. Spine 19:16 1842-1849, 1994.
David T: Lumbar disc prosthesis. Surgical technique, indications and clinical results in 22 patients with a minimum of 12 months follow-up. Eur S J (1993) 1:254-259