Clinical trial NCT02457468: The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
Official title: The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Keywords: coflex
interlaminar stabilization
lumbar spinal stenosis
neurogenic claudication
decompression
Lead sponsor: Predicted, Reported and Observed Outcomes Foundation
Sponsor class: OTHER
Collaborators: name: SPIRITT Research
First posted: 2015-05-29
Enrollment: 325
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
timeFrame: 5 years
measure: Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
timeFrame: 5 years
measure: Patient has not had any major device related complications
timeFrame: 5 years
measure: Patient has not undergone any Epidural injections
timeFrame: 5 years
Secondary outcomes:
measure: Zurich Claudication Questionnaire (ZCQ)
timeFrame: 5 years
measure: Quality of Life
timeFrame: 5 years
measure: VAS Leg Pain
timeFrame: 5 years
measure: VAS Back Pain
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Center for Neurology and Spine
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Brain and Spine
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists
state: Arizona
city: Santa Monica
country: United States
facility: The Spine Institute, Center for Spine Restoration
state: California
city: Fort Lauderdale
country: United States
facility: Cantor Spine institute
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical
state: Florida
city: Gainesville
country: United States
facility: The Orthopaedic Institute
state: Florida
city: Melbourne
country: United States
facility: The BACK Center
state: Florida
city: Saint Petersburg
country: United States
facility: All Florida Orthopaedics
state: Florida
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
city: Lawrenceville
country: United States
facility: OrthoAtlanta
state: Georgia
city: Palos Heights
country: United States
facility: Orthospine Center LTD
state: Illinois
city: Springfield
country: United States
facility: Orthopedic Center of Illinois
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's
state: Massachusetts
city: Springfield
country: United States
facility: New England Orthopedic Surgeons
state: Massachusetts
city: Saint Louis
country: United States
facility: The Orthopedic Center of St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Orthopedic Sports Medicine & Spine Care Institute
state: Missouri
city: Oradell
country: United States
facility: North Jersey Brain and Spine Center
state: New Jersey
city: Union
country: United States
facility: IGEA Brain and Spine
state: New Jersey
city: Roswell
country: United States
facility: Spine and Orhtopedic Center of New Mexico
state: New Mexico
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Arden
country: United States
facility: Blue Ridge Bone and Joint
state: North Carolina
city: Dublin
country: United States
facility: OrthoNeuro
state: Ohio
city: Sylvania
country: United States
facility: Consulting Orthopaedic Associates
state: Ohio
city: Carrollton
country: United States
facility: OrthoTexas
state: Texas
city: Dallas
country: United States
facility: Center for Spine Care
state: Texas
city: Seattle
country: United States
facility: NeoSpine
state: Washington
city: Cody
country: United States
facility: Bighorn Medical Center
state: Wyoming
Study officials:
References: