The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:2/21/2019
Start Date:June 2015
End Date:June 2023
Contact:Francine W Schranck
Email:fschranck@spirittresearch.com
Phone:314-738-8026

Use our guide to learn which trials are right for you!

The purpose of the coflexCOMMUNITY observational study is to collect information on patients
with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their
outcomes and the cost-effectiveness of this procedure.


Inclusion Criteria:

1. Patient is skeletally mature and has at least moderate impairment in function,
experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with
or without back pain, and has undergone at least 6 months of non-operative treatment;

2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the
coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected
level(s), where such use is not contraindicated as noted below.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at any index lumbar level;

2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current
or past trauma or tumor (e.g., compression fracture);

3. Severe facet hypertrophy that requires extensive bone removal which would cause
instability;

4. Grade II or greater spondylolisthesis;

5. Isthmic spondylolisthesis or spondylolysis (pars fracture);

6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);

7. Osteoporosis;

8. Back or leg pain of unknown etiology;

9. Axial back pain only, with no leg, buttock, or groin pain;

10. Morbid obesity defined as a body mass index > 40;

11. Active or chronic infection - systemic or local;

12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;

13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or
bladder dysfunction;

14. Vulnerable population including pregnant women, prisoners, students and employees of
treating physicians, and others who can be subject to coercion;

15. Patient is unwilling to complete his/her surveys.
We found this trial at
29
sites
Boston, Massachusetts 02115
Principal Investigator: Yi LU, MD, PhD
Phone: 314-738-8026
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205 East NASA Boulevard #200
Melbourne, Florida
Principal Investigator: James B. Billys, MD
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Melbourne, FL
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5860 N. La Cholla Blvd.
Tucson, Arizona 85704
520-742-1833
Principal Investigator: Thomas B Scully, MD
Phone: 314-738-8026
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Arden, North Carolina 28704
Principal Investigator: Stephen M. David, MD
Phone: 314-738-8026
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10215 Fernwood Road
Bethesda, Maryland 20817
Principal Investigator: Ira D. Fisch, MD
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Carrollton, Texas 75010
Principal Investigator: James A Guess, MD
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Cody, Wyoming 82414
Principal Investigator: Jeffrey Poffenbarger, MD
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Cooperstown, New York 13326
Principal Investigator: Reginald Q Knight, MD
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Dallas, Texas 75287
Principal Investigator: John H Peloza, MD
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Dublin, Ohio 43017
Principal Investigator: David K. Kim, MD
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Fort Lauderdale, Florida 33306
Principal Investigator: Jeffrey B. Cantor, MD
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Gainesville, Florida 32607
Principal Investigator: Steven M. Bailey, MD
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Gainesville, Florida 32607
Principal Investigator: Donald T Trimble, DO
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Lawrenceville, Georgia 30046
Principal Investigator: Tuan L Bui, MD
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Oradell, New Jersey 07649
Principal Investigator: Patrick A Roth, MD
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Palos Heights, Illinois 60463
Principal Investigator: William A Earman, Jr., DO
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Phoenix, Arizona 85032
Principal Investigator: Harvinder S Bedi, MD
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Roswell, New Mexico 88201
Principal Investigator: Omar N Osmani, MD
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Saint Louis, Missouri 63017
Principal Investigator: Matthew F Gornet, MD
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Saint Louis, Missouri 63122
Principal Investigator: David S Raskas, MD
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Saint Petersburg, Florida 33703
Principal Investigator: Paul J Pagano, MD
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Santa Monica, California 90403
Principal Investigator: Hyun W. Bae, MD
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Scottsdale, Arizona 85225
Principal Investigator: Mohamed Abdulhamid, MD
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Seattle, Washington 98372
Principal Investigator: Richard N W Wohns, MD
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Springfield, Illinois 62711
Principal Investigator: Timothy A VanFleet, MD
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300 Birnie Avenue
Springfield, Massachusetts 01107
Principal Investigator: Robert S Cowan, MD
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Sylvania, Ohio 43560
Principal Investigator: Thomas G. Andreshak, MD
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Tampa, Florida 33607
Principal Investigator: Reginald J Davis, MD
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Union, New Jersey 07083
Principal Investigator: Adam C Lipson, MD
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