RecruitingNot Applicable

Coflex PS3 Actual Conditions for Use Study

United States300 participantsStarted 2019-09-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

coflex performance compared to IDE

Timeframe: 24and 60 Months

coflex performance compared to decompression alone from ESCADA study.

Timeframe: 24 Months

Composite Clinical Success (CCS)

Timeframe: 24 Month

Trial details

NCT IDNCT02555280

SponsorXtant Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

Laura Henderson

406-813-4107 lhenderson@xtantmedical.com

View on ClinicalTrials.gov More Spinal Stenosis Lumbar trials