A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03928041|
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Lumbar Spondylolisthesis, Grade 1||Device: Device: EVOS Lumbar Interbody System (EVOS-HA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||All subjects will be recruited and receive the EVOS-HA prospectively.|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||October 2021|
single prospective study
All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA).
Device: Device: EVOS Lumbar Interbody System (EVOS-HA)
All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis.
- Interbody fusion rate [ Time Frame: 6 months post - operatively ]Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is 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 summarized into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0 to 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 uses to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand sleep, travel graded by score of 0-100 (0 = no disability and 100- maximum disability possible)
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): NCT03928041
|Contact: Karen Robson||+44 firstname.lastname@example.org|
|United States, North Carolina|
|OrthoCarolina Research Institute||Not yet recruiting|
|Charlotte, North Carolina, United States, 28207|
|Contact: Amy Roznowski|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Tiffany Morrison|
|Principal Investigator:||Mark Kurd, M.D.||Thomas Jefferson University|