The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
NCT ID: NCT02457468
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
325 participants
OBSERVATIONAL
2015-06-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stenosis patients treated with coflex
Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression
coflex
Interventions
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coflex
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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SPIRITT Research
UNKNOWN
Predicted, Reported and Observed Outcomes Foundation
OTHER
Responsible Party
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Locations
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Center for Neurology and Spine
Phoenix, Arizona, United States
Arizona Brain and Spine
Scottsdale, Arizona, United States
Northwest NeuroSpecialists
Tucson, Arizona, United States
The Spine Institute, Center for Spine Restoration
Santa Monica, California, United States
Cantor Spine institute
Fort Lauderdale, Florida, United States
Southeastern Integrated Medical
Gainesville, Florida, United States
The Orthopaedic Institute
Gainesville, Florida, United States
The BACK Center
Melbourne, Florida, United States
All Florida Orthopaedics
St. Petersburg, Florida, United States
Laser Spine Institute
Tampa, Florida, United States
OrthoAtlanta
Lawrenceville, Georgia, United States
Orthospine Center LTD
Palos Heights, Illinois, United States
Orthopedic Center of Illinois
Springfield, Illinois, United States
Brigham and Women's
Boston, Massachusetts, United States
New England Orthopedic Surgeons
Springfield, Massachusetts, United States
The Orthopedic Center of St. Louis
St Louis, Missouri, United States
Orthopedic Sports Medicine & Spine Care Institute
St Louis, Missouri, United States
North Jersey Brain and Spine Center
Oradell, New Jersey, United States
IGEA Brain and Spine
Union, New Jersey, United States
Spine and Orhtopedic Center of New Mexico
Roswell, New Mexico, United States
Bassett Medical Center
Cooperstown, New York, United States
Blue Ridge Bone and Joint
Arden, North Carolina, United States
OrthoNeuro
Dublin, Ohio, United States
Consulting Orthopaedic Associates
Sylvania, Ohio, United States
OrthoTexas
Carrollton, Texas, United States
Center for Spine Care
Dallas, Texas, United States
NeoSpine
Seattle, Washington, United States
Bighorn Medical Center
Cody, Wyoming, United States
Countries
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Other Identifiers
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SR-2015-01
Identifier Type: -
Identifier Source: org_study_id