The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
1 other identifier
observational
325
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 24, 2019
February 1, 2019
4.5 years
May 10, 2015
December 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
5 years
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
5 years
Patient has not had any major device related complications
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
5 years
Patient has not undergone any Epidural injections
Assessment of lumbar epidural injections
5 years
Secondary Outcomes (4)
Zurich Claudication Questionnaire (ZCQ)
5 years
Quality of Life
5 years
VAS Leg Pain
5 years
VAS Back Pain
5 years
Study Arms (1)
Stenosis patients treated with coflex
Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression
Interventions
Eligibility Criteria
Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression
You may qualify if:
- 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;
- 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.
You may not qualify if:
- Prior fusion or decompressive laminectomy at any index lumbar level;
- Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
- Severe facet hypertrophy that requires extensive bone removal which would cause instability;
- Grade II or greater spondylolisthesis;
- Isthmic spondylolisthesis or spondylolysis (pars fracture);
- Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
- Osteoporosis;
- Back or leg pain of unknown etiology;
- Axial back pain only, with no leg, buttock, or groin pain;
- Morbid obesity defined as a body mass index \> 40;
- Active or chronic infection - systemic or local;
- Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
- Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
- Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
- Patient is unwilling to complete his/her surveys.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Center for Neurology and Spine
Phoenix, Arizona, 85032, United States
Arizona Brain and Spine
Scottsdale, Arizona, 85225, United States
Northwest NeuroSpecialists
Tucson, Arizona, 85741, United States
The Spine Institute, Center for Spine Restoration
Santa Monica, California, 90403, United States
Cantor Spine institute
Fort Lauderdale, Florida, 33306, United States
Southeastern Integrated Medical
Gainesville, Florida, 32607, United States
The Orthopaedic Institute
Gainesville, Florida, 32607, United States
The BACK Center
Melbourne, Florida, 32901, United States
All Florida Orthopaedics
St. Petersburg, Florida, 33703, United States
Laser Spine Institute
Tampa, Florida, 33607, United States
OrthoAtlanta
Lawrenceville, Georgia, 30046, United States
Orthospine Center LTD
Palos Heights, Illinois, 60463, United States
Orthopedic Center of Illinois
Springfield, Illinois, 62711, United States
Brigham and Women's
Boston, Massachusetts, 02115, United States
New England Orthopedic Surgeons
Springfield, Massachusetts, 01107, United States
The Orthopedic Center of St. Louis
St Louis, Missouri, 63017, United States
Orthopedic Sports Medicine & Spine Care Institute
St Louis, Missouri, 63122, United States
North Jersey Brain and Spine Center
Oradell, New Jersey, 07649, United States
IGEA Brain and Spine
Union, New Jersey, 07083, United States
Spine and Orhtopedic Center of New Mexico
Roswell, New Mexico, 88201, United States
Bassett Medical Center
Cooperstown, New York, 13326, United States
Blue Ridge Bone and Joint
Arden, North Carolina, 28704, United States
OrthoNeuro
Dublin, Ohio, 43017, United States
Consulting Orthopaedic Associates
Sylvania, Ohio, 43560, United States
OrthoTexas
Carrollton, Texas, 75010, United States
Center for Spine Care
Dallas, Texas, 75287, United States
NeoSpine
Seattle, Washington, 98372, United States
Bighorn Medical Center
Cody, Wyoming, 82414, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2015
First Posted
May 29, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
December 24, 2019
Record last verified: 2019-02