SAIF: Sacroiliac Fusion Study (SAIF)
|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: NCT02064322|
Recruitment Status : Terminated
First Posted : February 17, 2014
Last Update Posted : March 31, 2016
|Condition or disease||Intervention/treatment|
|Sacroiliac Joint Dysfunction||Device: SImmetry Implant|
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Subjects who are indicated for the SImmetry Device according to the approved product labeling and inclusion/exclusion criteria will receive a SImmetry implant.
Device: SImmetry Implant
The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, 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 ]Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
- 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 and 24 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.