Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02074761|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2014
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment|
|Sacroiliac Joint Dysfunction||Device: SImmetry|
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System|
|Actual Study Start Date :||January 6, 2015|
|Actual Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||November 2020|
Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.
The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion.
The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.
- SI Joint Fusion [ Time Frame: 12 months ]Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory
- SI Joint Pain Reduction [ Time Frame: 6 Months ]SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.
- SI Joint Pain Reduction [ Time Frame: 12 months ]SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
- Disability [ Time Frame: 6 months ]Functional ability as determined by the Oswestry Disability Index
- Quality of Life [ Time Frame: 6 months ]Quality of life as determined by EQ-5D
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): NCT02074761