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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis
• Intervention / Treatment: Device: coflex

• Study Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Center for Neurology and Spine
    • Scottsdale, Arizona, United States, 85225
      • Arizona Brain and Spine
    • Tucson, Arizona, United States, 85741
      • Northwest NeuroSpecialists
  • California
    • Santa Monica, California, United States, 90403
      • The Spine Institute, Center for Spine Restoration
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
      • Cantor Spine Institute
    • Gainesville, Florida, United States, 32607
      • Southeastern Integrated Medical
    • Gainesville, Florida, United States, 32607
      • The Orthopaedic Institute
    • Melbourne, Florida, United States, 32901
      • The BACK Center
    • Saint Petersburg, Florida, United States, 33703
      • All Florida Orthopaedics
    • Tampa, Florida, United States, 33607
      • Laser Spine Institute
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • OrthoAtlanta
  • Illinois
    • Palos Heights, Illinois, United States, 60463
      • Orthospine Center LTD
    • Springfield, Illinois, United States, 62711
      • Orthopedic Center of Illinois
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's
    • Springfield, Massachusetts, United States, 01107
      • New England Orthopedic Surgeons
  • Missouri
    • Saint Louis, Missouri, United States, 63017
      • The Orthopedic Center of St. Louis
    • Saint Louis, Missouri, United States, 63122
      • Orthopedic Sports Medicine & Spine Care Institute
  • New Jersey
    • Oradell, New Jersey, United States, 07649
      • North Jersey Brain and Spine Center
    • Union, New Jersey, United States, 07083
      • IGEA Brain and Spine
  • New Mexico
    • Roswell, New Mexico, United States, 88201
      • Spine and Orhtopedic Center of New Mexico
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
  • North Carolina
    • Arden, North Carolina, United States, 28704
      • Blue Ridge Bone and Joint
  • Ohio
    • Dublin, Ohio, United States, 43017
      • OrthoNeuro
    • Sylvania, Ohio, United States, 43560
      • Consulting Orthopaedic Associates
  • Texas
    • Carrollton, Texas, United States, 75010
      • OrthoTexas
    • Dallas, Texas, United States, 75287
      • Center for Spine Care
  • Washington
    • Seattle, Washington, United States, 98372
      • NeoSpine
  • Wyoming
    • Cody, Wyoming, United States, 82414
      • Bighorn Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stenosis patients treated with coflex; Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression	Device: coflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zurich Claudication Questionnaire (ZCQ)	ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.	5 years
Quality of Life	Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L	5 years
VAS Leg Pain	Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).	5 years
VAS Back Pain	Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).	5 years

Collaborators and Investigators

• Sponsor: Predicted, Reported and Observed Outcomes Foundation
• Collaborators: SPIRITT Research

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 10, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: decompression; neurogenic claudication; lumbar spinal stenosis; coflex; interlaminar stabilization
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: SR-2015-01