Coflex PS3 Actual Conditions for Use Study
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.
Xtant Medical
300 participants
Sep 9, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
- Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
- Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
- 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.
- Skeletally mature
- Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
- Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
- 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 Criteria12
- Prior fusion or decompressive laminectomy at index lumbar level.
- Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
- Severe facet hypertrophy that requires extensive bone removal which would cause instability.
- Isthmic spondylolisthesis or spondylolysis (pars fracture).
- Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
- Osteoporsis or is at increased risk of osteoporosis.
- Back or leg pain of unknown etiology.
- Axial back pain only, with no leg, buttock, or groin pain.
- Morbid obesity defined as a body mass index \> 40.
- Known allergy to titanium, titanium alloys, or MR contrast agents.
- Active or chronic infection - systemic or local.
- Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
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Interventions
Decompression plus coflex® Interlaminar Technology
Decompression alone
Locations(19)
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NCT02555280