Clinical trial NCT02555280: Coflex PS3 Actual Conditions for Use Study
Official title: A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Stenosis Lumbar
Keywords: moderate lumbar stenosis
neurogenic claudication
spinal stenosis
low back pain
decompression
Lead sponsor: Xtant Medical
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2015-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Detailed description: A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.

Eligibility criteria: Inclusion Criteria:

1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
5. Skeletally mature
6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at 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. Isthmic spondylolisthesis or spondylolysis (pars fracture).
5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
6. Osteoporsis or is at increased risk of osteoporosis.
7. Back or leg pain of unknown etiology.
8. Axial back pain only, with no leg, buttock, or groin pain.
9. Morbid obesity defined as a body mass index \> 40.
10. Known allergy to titanium, titanium alloys, or MR contrast agents.
11. Active or chronic infection - systemic or local.
12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

Primary outcomes:
measure: coflex performance compared to IDE
timeFrame: 24and 60 Months
measure: coflex performance compared to decompression alone from ESCADA study.
timeFrame: 24 Months
measure: Composite Clinical Success (CCS)
timeFrame: 24 Month
Secondary outcomes:
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Baseline, 24 and 60 months
measure: Change in Visual Analog Scale (VAS) for low back pain
timeFrame: Baseline, 24 and 60 Months
measure: Change in Visual Analog Scale (VAS) for leg pain
timeFrame: Baseline, 24 and 60 Months
measure: Neurological Status
timeFrame: Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
measure: Radiographic Assessments
timeFrame: 6 weeks, 12, 24, 60 Months
measure: Modified CCS
timeFrame: 24 Month
measure: Medication Usage
timeFrame: 24 Month
Other outcomes:
measure: Safety Evaluation
timeFrame: Procedure, 6 week, 12, 24, 36, 48, 60 Months
Locations:
city: Phoenix
country: United States
facility: Desert Institute for Spine Care (DISC)
state: Arizona
city: Irvine
country: United States
facility: Hoag Orthopedics
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: San Luis Obispo
country: United States
facility: Central Cost Neurological Surgery
state: California
city: Santa Monica
country: United States
facility: Cervical Disc Center of Los Angeles
state: California
city: Aurora
country: United States
facility: UC Health Spine Center
state: Colorado
city: Durango
country: United States
facility: Mercy Regional Medical Center
state: Colorado
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Evanston
country: United States
facility: 01L_Northshore University Health System
state: Illinois
city: Lafayette
country: United States
facility: 24_Unity Surgical Center, LLC
state: Indiana
city: Munster
country: United States
facility: Orthopaedic Specialist of Northwest Indiana
state: Indiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Wayne
country: United States
facility: St. Joseph's Medical Center
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health Physician Partners Orthopaedic Institute at Great Neck
state: New York
city: Toledo
country: United States
facility: Consulting Orthopaedic Associates
state: Ohio
city: Medford
country: United States
facility: Southern Oregon Orthpaedics
state: Oregon
city: Portland
country: United States
facility: Summit Spine
state: Oregon
city: Philadelphia
country: United States
facility: 03L_Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: Austin Neurosurgeons
state: Texas
Study officials:
References: