Actively Recruiting
Coflex PS3 Actual Conditions for Use Study
Led by Xtant Medical · Updated on 2024-01-05
300
Participants Needed
19
Research Sites
425 weeks
Total Duration
On this page
Sponsors
X
Xtant Medical
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coflex PS3 Actual Conditions for Use Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 requiring surgical decompression
- Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale
- Neurogenic claudication with leg, buttock, or groin pain relieved by flexion such as sitting
- Prior lumbar injection at any time and/or at least 6 months of prior conservative care without adequate symptom relief
- Skeletally mature adults
- Oswestry Low Back Pain Disability Questionnaire score of at least 20 out of 50 (40%)
- Mentally, psychosocially, and physically able to comply with the protocol, including visits and forms
- Signed informed consent before any study procedures
You will not qualify if you...
- Prior fusion or decompressive laminectomy at the lumbar index level
- Radiographically compromised vertebral bodies at any lumbar level due to trauma or tumor
- Severe facet hypertrophy requiring extensive bone removal causing instability
- Isthmic spondylolisthesis or spondylolysis (pars fracture)
- Degenerative lumbar scoliosis with Cobb angle greater than 25 degrees
- Osteoporosis or increased risk of osteoporosis
- Back or leg pain of unknown cause
- Axial back pain only without leg, buttock, or groin pain
- Morbid obesity with body mass index over 40
- Known allergy to titanium, titanium alloys, or MR contrast agents
- Active or chronic systemic or local infection
- Cauda equina syndrome with neurogenic bowel or bladder dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Desert Institute for Spine Care (DISC)
Phoenix, Arizona, United States, 85020
Actively Recruiting
2
Hoag Orthopedics
Irvine, California, United States, 92618
Withdrawn
3
Sutter Health
Sacramento, California, United States, 95816
Actively Recruiting
4
Central Cost Neurological Surgery
San Luis Obispo, California, United States, 93401
Actively Recruiting
5
Cervical Disc Center of Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
6
UC Health Spine Center
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Mercy Regional Medical Center
Durango, Colorado, United States, 81301
Withdrawn
8
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
Terminated
9
01L_Northshore University Health System
Evanston, Illinois, United States, 60201
Completed
10
24_Unity Surgical Center, LLC
Lafayette, Indiana, United States, 47905
Terminated
11
Orthopaedic Specialist of Northwest Indiana
Munster, Indiana, United States, 46321
Withdrawn
12
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Terminated
13
St. Joseph's Medical Center
Wayne, New Jersey, United States, 07470
Withdrawn
14
Northwell Health Physician Partners Orthopaedic Institute at Great Neck
Great Neck, New York, United States, 11021
Actively Recruiting
15
Consulting Orthopaedic Associates
Toledo, Ohio, United States, 43617
Withdrawn
16
Southern Oregon Orthpaedics
Medford, Oregon, United States, 97504
Actively Recruiting
17
Summit Spine
Portland, Oregon, United States, 97225
Actively Recruiting
18
03L_Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Terminated
19
Austin Neurosurgeons
Austin, Texas, United States, 78746
Actively Recruiting
Research Team
L
Laura Henderson
CONTACT
I
Isabella Rosales
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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