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

Completed

• Conditions: Spinal Stenosis

• 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

Study Timeline

• Study First Submitted: 2015-05-10
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Study Start: 2015-06
• Status Verified: 2019-02
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

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; 🇺🇸 Saint Petersburg, Florida, United States

Laser Spine Institute; 🇺🇸 Tampa, Florida, United States

Scroll for more (18 remaining)