The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
- Conditions
- Spinal Stenosis
- Interventions
- Device: coflex
- Registration Number
- NCT02457468
- Lead Sponsor
- Predicted, Reported and Observed Outcomes Foundation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stenosis patients treated with coflex coflex Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression
- Primary Outcome Measures
Name Time Method Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery 5 years 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
Patient has not had any major device related complications 5 years 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.
Patient has not undergone any Epidural injections 5 years Assessment of lumbar epidural injections
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations; 5 years Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
- Secondary Outcome Measures
Name Time Method Zurich Claudication Questionnaire (ZCQ) 5 years ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
Quality of Life 5 years Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
VAS Back Pain 5 years Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
VAS Leg Pain 5 years Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
Trial Locations
- Locations (28)
All Florida Orthopaedics
🇺🇸Saint Petersburg, Florida, United States
Laser Spine Institute
🇺🇸Tampa, Florida, United States
Orthospine Center LTD
🇺🇸Palos Heights, Illinois, United States
Orthopedic Center of Illinois
🇺🇸Springfield, Illinois, United States
The Orthopedic Center of St. Louis
🇺🇸Saint Louis, Missouri, United States
Orthopedic Sports Medicine & Spine Care Institute
🇺🇸Saint Louis, Missouri, United States
New England Orthopedic Surgeons
🇺🇸Springfield, Massachusetts, 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
OrthoTexas
🇺🇸Carrollton, Texas, United States
Consulting Orthopaedic Associates
🇺🇸Sylvania, Ohio, United States
The Spine Institute, Center for Spine Restoration
🇺🇸Santa Monica, California, United States
Cantor Spine institute
🇺🇸Fort Lauderdale, Florida, United States
OrthoNeuro
🇺🇸Dublin, Ohio, United States
Center for Spine Care
🇺🇸Dallas, Texas, United States
Brigham and Women's
🇺🇸Boston, Massachusetts, United States
NeoSpine
🇺🇸Seattle, Washington, United States
Arizona Brain and Spine
🇺🇸Scottsdale, Arizona, United States
Center for Neurology and Spine
🇺🇸Phoenix, Arizona, United States
The Orthopaedic Institute
🇺🇸Gainesville, Florida, United States
OrthoAtlanta
🇺🇸Lawrenceville, Georgia, United States
Southeastern Integrated Medical
🇺🇸Gainesville, Florida, United States
The BACK Center
🇺🇸Melbourne, Florida, United States
Northwest NeuroSpecialists
🇺🇸Tucson, Arizona, United States
Bighorn Medical Center
🇺🇸Cody, Wyoming, United States