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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFuse Implant System | Experimental | Surgical placement of iFuse implants in the affected SI joint |
|
| conservative management | Active Comparator | Medications, physical therapy, information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse Implant System | Device | Placement of iFuse implant system via surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lower back pain (VAS) | 1, 3, 12 and 24 months | |
| Change from baseline in leg pain (VAS | 1, 3, 6, 12 and 24 months | |
| Change in disability due to back pain (ODI |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical re-interventions of target SI joint(s) | over 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cher | SI-BONE, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| La Clinique de l'Espérance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38081463 | Derived | Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9. | |
| 28934785 | Derived | Dengler JD, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017 Sep;20(6):537-550. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| publication 6 month results | View IPD |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2019 | |
| Reset | Oct 11, 2019 | |
| Release | Sep 9, 2020 | |
| Reset | Sep 30, 2020 | |
| Release | Sep 21, 2021 | |
| Reset | Oct 19, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2019 | Oct 11, 2019 | |||
| Sep 9, 2020 |
| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Conservative Management |
| Other |
Medications for pain, physical therapy, cognitive behavour therapy |
|
| 3, 6, 12 and 24 months |
| Change in quality of life (EQ-5D | 3, 6, 12 and 24 months |
| Change in ambulatory and work status | 1, 3, 6, 12 and 24 months |
| Change in depression score (Zung Depression Scale | 3, 6, 12 and 24 months |
| Change in objective functional test (ASLR | 3, 6, 12 and 24 months |
| Change in walking distance | 3, 6, 12 and 24 months |
| Patient satisfaction and self-rating of disease state | 3, 6, 12 and 24 months |
| Serious adverse events | during 24 months |
| Device breakage, loosening and migration | 12 months |
| Montegnée |
| 4420 |
| Belgium |
| Charité - Universitätsmedizin Berlin | Berlin | 12200 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Praxisgemeinschaft "Leben in Bewegung" | Hilden | 40721 | Germany |
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Ospedale Civile Di Legnano | Legnano | 20025 | Italy |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Aleris Specialistvård Ängelholm, Ortopedkliniken | Ängelholm | 26262 | Sweden |
| 27629371 | Derived | Dengler J, Sturesson B, Kools D, Prestamburgo D, Cher D, van Eeckhoven E, Erk E, Pflugmacher R, Vajkoczy P; the iMIA study group. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). 2016 Nov;158(11):2219-2224. doi: 10.1007/s00701-016-2953-7. Epub 2016 Sep 15. |
| 27179664 | Derived | Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. 2017 Mar;26(3):708-719. doi: 10.1007/s00586-016-4599-9. Epub 2016 May 14. |
| publication 6 month results | View IPD |
| Sep 30, 2020 |
| Sep 21, 2021 | Oct 19, 2021 |