Evidence For Fusion In Spine With Orthoss® (EFFISO)
|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: NCT03853356|
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment|
|Lumbar Spondylolisthesis Involving L4-L5 Lumbar Spondylolisthesis Involving L5-S1 Lumbar Spinal Stenosis Lumbar Disc Degeneration||Device: Orthoss|
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|Official Title:||Evidence For Fusion In Spine With Orthoss®|
|Actual Study Start Date :||January 18, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
|Lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1)||
Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
- Fusion rate [ Time Frame: 6 months ]Successful fusion should be based on the translational motion < 3mm as well as on the angular motion < 5° at 6 months.
- Clinical Outcome Measure - Quality of Life: Oswestry Low Back Disability Index [ Time Frame: 1-4 weeks; 3, 6, 12 and 24 months ]Improvement in Oswestry Low Back Disability Index (ODI) of 15 or more at 24 months from the pre-operative value.Zero is equated with no disability and 100 is the maximum disability possible.
- Clinical Outcome Measure - Leg pain [ Time Frame: 1-4 weeks, 3,6,12 and 24 months ]Decrease in Visual Analog Scale for Pain (VAS) for leg by 3/10 or more at 24 months from the pre-operative value. Patients rated their leg pain intesity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
- Clinical Outcome Measure - Back pain [ Time Frame: 1- ]Decrease in Visual Analog Scale for Pain (VAS) for back by 3/10 or more at 24 months from the pre-operative value. Patients rated their back pain intesity on a scale from 0-10, with a score of 0 representing "no pain" and a score fo 10 representing "pain as bad as it could be".
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): NCT03853356
|Contact: Markus Konieczny, MD 211 - 81 18314 ext +49 Markus.Konieczny@med.uni-duesseldorf.de|
|Principal Investigator: Markus Konieczny, MD|
|Klinikum Magdeburg gGmbH||Recruiting|
|Contact: Jörg Franke, MD 0391 791-5201 ext +49 Joerg.Franke@Klinikum-Magdeburg.de|
|Principal Investigator: Jörg Franke, MD|
|Klinikum rechts der Isar Technische Universität München||Recruiting|
|Contact: Ehab Shiban, MD 089 / 4140 9715 ext +49 email@example.com|
|Principal Investigator: Ehab Shiban, MD|