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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
Primary Outcome
Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,\& Absence of surgical re-intervention on the target SI joint(s).
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 |
What the finished NCT02270203 record still lists
NCT02270203 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Pelvic CT at 5 years post-op is the first listed.
NCT02270203 does not publish any study locations in the registry export this page uses.
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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