An interventional study of Surgery with the Keos Lumbar Interbody Fusion Device in Degenerative Disc Disease, Spondylolisthesis and Retrolisthesis, sponsored by Invibio Ltd. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Invibio Ltd · Not applicable, Interventional, and Treatment
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.
This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Invibio Ltd is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.
Device: Surgery with the Keos Lumbar Interbody Fusion Device
All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis
Interbody fusion rate
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
Time frame: 6 months post - operatively
To measure how much pain the subject is in according to a pain scale 0-10
Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)
Time frame: 6 weeks, 3, 6, 12 and 24 months post operatively
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12
Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarised into Physical and Mental Health Composite Scores (PCS \& MCS) and range from 0-100. The lower the score the more disability. The higher the score the less disability i.e.a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Functional Impairment
Questionnaire ODI (Oswestry Disability Index) - disability questionnaire used to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand, sleep, travel and graded by score of 0-100 (0= no disability and 100= maximum disability possible)
Time frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
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