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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457468
• Other study ID #: SR-2015-01
• Status: Completed
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Predicted, Reported and Observed Outcomes Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Device:
• coflex

Locations

Country	Name	City	State
United States	Blue Ridge Bone and Joint	Arden	North Carolina
United States	Brigham and Women's	Boston	Massachusetts
United States	OrthoTexas	Carrollton	Texas
United States	Bighorn Medical Center	Cody	Wyoming
United States	Bassett Medical Center	Cooperstown	New York
United States	Center for Spine Care	Dallas	Texas
United States	OrthoNeuro	Dublin	Ohio
United States	Cantor Spine institute	Fort Lauderdale	Florida
United States	Southeastern Integrated Medical	Gainesville	Florida
United States	The Orthopaedic Institute	Gainesville	Florida
United States	OrthoAtlanta	Lawrenceville	Georgia
United States	The BACK Center	Melbourne	Florida
United States	North Jersey Brain and Spine Center	Oradell	New Jersey
United States	Orthospine Center LTD	Palos Heights	Illinois
United States	Center for Neurology and Spine	Phoenix	Arizona
United States	Spine and Orhtopedic Center of New Mexico	Roswell	New Mexico
United States	Orthopedic Sports Medicine & Spine Care Institute	Saint Louis	Missouri
United States	The Orthopedic Center of St. Louis	Saint Louis	Missouri
United States	All Florida Orthopaedics	Saint Petersburg	Florida
United States	The Spine Institute, Center for Spine Restoration	Santa Monica	California
United States	Arizona Brain and Spine	Scottsdale	Arizona
United States	NeoSpine	Seattle	Washington
United States	New England Orthopedic Surgeons	Springfield	Massachusetts
United States	Orthopedic Center of Illinois	Springfield	Illinois
United States	Consulting Orthopaedic Associates	Sylvania	Ohio
United States	Laser Spine Institute	Tampa	Florida
United States	Northwest NeuroSpecialists	Tucson	Arizona
United States	IGEA Brain and Spine	Union	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Predicted, Reported and Observed Outcomes Foundation	SPIRITT Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Patient has not undergone any Epidural injections	Assessment of lumbar epidural injections	5 years
Secondary	Zurich Claudication Questionnaire (ZCQ)	ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.	5 years
Secondary	Quality of Life	Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L	5 years
Secondary	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
Secondary	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