Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Keos LLC | UNKNOWN |
| Medical Metrics Diagnostics, Inc | INDUSTRY |
| Technomics Research | INDUSTRY |
| Viedoc Technologies |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Other | All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with the Keos Lumbar Interbody Fusion Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Interbody fusion rate | Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments | 6 months post - operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louis A Marotti, M.D. PhD | Neurosurgical Associates of Lancaster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurosurgical Associates of Lancaster | Lancaster | Pennsylvania | 17601 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
| UNKNOWN |
All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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) | pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively |
| D055009 |
| Spondylosis |