A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
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|ClinicalTrials.gov Identifier: NCT04416321|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : August 5, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Spondylolisthesis Retrolisthesis||Device: Surgery with the Keos Lumbar Interbody Fusion Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
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 [ Time Frame: 6 months post - operatively ]Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
- To measure how much pain the subject is in according to a pain scale 0-10 [ Time Frame: 6 weeks, 3, 6, 12 and 24 months post operatively ]Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)
- To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12 [ Time Frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively ]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.
- Functional Impairment [ Time Frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively ]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)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416321
|Contact: Karen Robson||+44 7765 firstname.lastname@example.org|
|Contact: Sheryl O'Farrell||+44 email@example.com|
|United States, Pennsylvania|
|Neurosurgical Associates of Lancaster||Recruiting|
|Lancaster, Pennsylvania, United States, 17601|
|Contact: Nichole Beaty 717-358-0800 ext 215 firstname.lastname@example.org|
|Principal Investigator:||Louis A Marotti, M.D. PhD||Neurosurgical Associates of Lancaster|
|Responsible Party:||Invibio Ltd|
|Other Study ID Numbers:||
|First Posted:||June 4, 2020 Key Record Dates|
|Last Update Posted:||August 5, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Lumbar Degenerative Disc Disease
Intervertebral Disc Degeneration