iFuse Implant System® Minimally Invasive Arthrodesis (iMIA)
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ClinicalTrials.gov Identifier: NCT01741025 |
Recruitment Status :
Completed
First Posted : December 4, 2012
Last Update Posted : October 3, 2017
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Sponsor:
SI-BONE, Inc.
Information provided by (Responsible Party):
SI-BONE, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | November 30, 2012 | |||
First Posted Date ICMJE | December 4, 2012 | |||
Last Update Posted Date | October 3, 2017 | |||
Study Start Date ICMJE | June 2013 | |||
Actual Primary Completion Date | December 15, 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
Surgical re-interventions of target SI joint(s) [ Time Frame: over 24 months ] | |||
Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | iFuse Implant System® Minimally Invasive Arthrodesis | |||
Official Title ICMJE | A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain. | |||
Brief Summary | The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint | |||
Detailed Description | This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Sacroiliac Joint Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
103 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | September 24, 2017 | |||
Actual Primary Completion Date | December 15, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Germany, Italy, Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01741025 | |||
Other Study ID Numbers ICMJE | 300134 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | SI-BONE, Inc. | |||
Study Sponsor ICMJE | SI-BONE, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | SI-BONE, Inc. | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |