A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine

Conditions
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Retrolisthesis, Degenerative Disc Disease, Spondylolisthesis

Intervention / Treatment
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* Device: Surgery with the Keos Lumbar Interbody Fusion Device


Participation Criteria
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Eligibility Criteria
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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. Able to give voluntary, written informed consent to participate. 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. Evidence of an active infection. Any conditions outlined as contraindicated in the Instructions for Use. Receiving any drug treatment that may affect bone metabolism. Female subjects who are pregnant or lactating. Current smokers or have stopped smoking less than 6 months ago. Known drug or alcohol abusers. Currently enrolled in a clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis