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NCT02270203 · ClinicalTrials.gov registry record
LOIS: Long-Term Follow-Up in INSITE/SIFI
A clinical trial, sponsored by SI-BONE.
- Completed
- Registry status
- 103
- Enrollment target
NCT02270203: Completed study, sponsored by SI-BONE.
NCT02270203 is a clinical trial that has completed, run by SI-BONE. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02270203 has completed, sponsored by SI-BONE.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD). Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are: * SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and * INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement
Interventions
- RADIATION Pelvic CT at 5 years post-op
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02270203
The ClinicalTrials.gov registry entry for NCT02270203 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SI-BONE, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pelvic CT at 5 years post-op is the first listed.
NCT02270203 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02270203 about?
NCT02270203 is a clinical study titled "LOIS: Long-Term Follow-Up in INSITE/SIFI". The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD). Study Design: This study is extended follow-up from two ongoing multicenter pro...
What is the current status of trial NCT02270203?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2014-10. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02270203?
The interventions under investigation include: Pelvic CT at 5 years post-op (RADIATION).
Who is sponsoring clinical trial NCT02270203?
This trial is sponsored by SI-BONE, which has 10 total clinical trials registered on ClinicalTrials.gov.
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