Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2019-09-09
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The coflex® Interlaminar Technology
The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
Decompression
Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.
Decompression
Decompression alone
Interventions
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coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
Decompression
Decompression alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Xtant Medical
INDUSTRY
Responsible Party
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Locations
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Desert Institute for Spine Care (DISC)
Phoenix, Arizona, United States
Hoag Orthopedics
Irvine, California, United States
Sutter Health
Sacramento, California, United States
Central Cost Neurological Surgery
San Luis Obispo, California, United States
Cervical Disc Center of Los Angeles
Santa Monica, California, United States
UC Health Spine Center
Aurora, Colorado, United States
Mercy Regional Medical Center
Durango, Colorado, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
01L_Northshore University Health System
Evanston, Illinois, United States
24_Unity Surgical Center, LLC
Lafayette, Indiana, United States
Orthopaedic Specialist of Northwest Indiana
Munster, Indiana, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
St. Joseph's Medical Center
Wayne, New Jersey, United States
Northwell Health Physician Partners Orthopaedic Institute at Great Neck
Great Neck, New York, United States
Consulting Orthopaedic Associates
Toledo, Ohio, United States
Southern Oregon Orthpaedics
Medford, Oregon, United States
Summit Spine
Portland, Oregon, United States
03L_Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Austin Neurosurgeons
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PS3/P110008
Identifier Type: -
Identifier Source: org_study_id
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