Coflex PS3 Actual Conditions for Use Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02555280
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xtant Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Stenosis Lumbar

Additional Details

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.

Arms & Interventions

Arms

Other: 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.

Active Comparator: 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.

Interventions

Device: - coflex® Interlaminar Technology

Decompression plus coflex® Interlaminar Technology

Procedure: - Decompression

Decompression alone

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Desert Institute for Spine Care (DISC), Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Desert Institute for Spine Care (DISC)

Phoenix 5308655, Arizona 5551752, 85020

Site Contact

Jennifer Camoriano

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