Coflex PS3 Actual Conditions for Use Study

Launched by XTANT MEDICAL · Sep 18, 2015

Keywords

ClinConnect Summary

The Coflex PS3 Actual Conditions for Use Study is a clinical trial examining how effective a treatment called coflex® Interlaminar Technology is for patients with spinal stenosis in the lower back, especially those also experiencing back pain. This study will follow participants over two and five years to see how well this treatment helps relieve their symptoms. To be eligible, participants should be between 65 and 74 years old and have been diagnosed with moderate spinal stenosis that requires surgery. They should also have experienced significant back pain and have not found relief from other treatments like injections or physical therapy.

Participants in this study can expect to undergo a surgical procedure aimed at relieving their spinal stenosis, which is a narrowing of the spine that can cause pain and discomfort. Throughout the trial, they will have scheduled visits to monitor their progress and complete various assessments related to their condition. It's important to note that certain individuals, such as those with severe back issues or specific health concerns, may not qualify for the study. This trial is actively recruiting participants who meet the criteria, and those interested should discuss the opportunity with their healthcare provider.

Gender

ALL

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.