A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMAâ„¢ HA Enhanced. (NCT04416321) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMAâ„¢ HA Enhanced.
United States25 participantsStarted 2021-07-01
Plain-language summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
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
✓. Aged 18 years of age or older.
✓. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1.
✓. Have discogenic back pain.
✓. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
✓. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
✓. Completed at least 6 months of conservative non-operative treatment.
✓. Female subjects of childbearing age must have a negative pregnancy test.
✓. Able to understand this clinical study, co-operate with procedures.
Exclusion criteria
✕. Not undergone previous spinal surgery at the affected disc level(s).
✕. Evidence of tumour and/or malignant disease.
✕. Known osteoporosis or severe osteopenia.
✕. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised.
✕. Known allergy to the material used in the instrumentation.