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| Name | Class |
|---|---|
| SI-BONE, Inc. | INDUSTRY |
| Johannes Gutenberg University Mainz | OTHER |
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Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps.
The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients.
The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFuse-3D | Experimental | Titanium fusion implant in combination with trans-iliac screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse-3D implant | Device | The iFuse Implant System consists of cannulated triangular titanium implants (Ti 6AI4V ELI, ASTM F136) with a porous coating of commercially pure titanium plasma spray (C.P. Ti, ASTM F1580) and a setting instrument. The coating and special shape of the implants prevent rotation or displacement of the sacroiliac (SI) joint. The placement instrument uses guide pins to achieve precise placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who regain their pre-fracture mobility as measured by the FMS by the time of hospital discharge | The proportion is shown with frequencies and corresponding percentages. | Time 8 days (discharge) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve pre-fracture mobility within six weeks. | The proportion is shown with frequencies and corresponding percentages. | Time six weeks after surgery |
| Proportion of patients who achieve pre-fracture mobility at three months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erol Gercek, Prof. | University Medical Center of the Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonie Krankenhaus | Bad Kreuznach | 55543 | Germany | |||
| University Medical Center of the Johannes Gutenberg University Mainz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24762143 | Background | Sullivan MP, Baldwin KD, Donegan DJ, Mehta S, Ahn J. Geriatric fractures about the hip: divergent patterns in the proximal femur, acetabulum, and pelvis. Orthopedics. 2014 Mar;37(3):151-7. doi: 10.3928/01477447-20140225-50. | |
| 29684740 | Background | Kannus P, Niemi S, Parkkari J, Sievanen H. Continuously declining incidence of hip fracture in Finland: Analysis of nationwide database in 1970-2016. Arch Gerontol Geriatr. 2018 Jul-Aug;77:64-67. doi: 10.1016/j.archger.2018.04.008. Epub 2018 Apr 17. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D015775 | Fractures, Stress |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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|
The proportion is shown with frequencies and corresponding percentages. |
| Time three months after surgery |
| Proportion of patients who achieve pre-fracture mobility at six months. | The proportion is shown with frequencies and corresponding percentages. | Time six months after surgery |
| Proportion of patients who achieve pre-fracture mobility at 12 months. | The proportion is shown with frequencies and corresponding percentages. | Time 12 months after surgery |
| Proportion of patients who achieved an FMS ≥ 2 (= walking with assistive devices) at discharge. | The proportion is shown with frequencies and corresponding percentages. | Time 8 days (discharge) after surgery |
| Proportion of patients who achieved an FMS ≥ 2 within six weeks. | The proportion is shown with frequencies and corresponding percentages. | Time six weeks after surgery |
| Proportion of patients who achieved an FMS ≥ 2 at three months. | The proportion is shown with frequencies and corresponding percentages. | Time three months after surgery |
| Proportion of patients who achieved an FMS ≥ 2 at six months. | The proportion is shown with frequencies and corresponding percentages. | Time six months after surgery |
| Proportion of patients who achieved an FMS ≥ 2 at 12 months. | The proportion is shown with frequencies and corresponding percentages. | Time 12 months after surgery |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) within six weeks. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at three months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at six months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery |
| Change in posterior pelvic girdle pain at rest and when attempting to walk measured by a NRS (0-10) at 12 months. | Appropriate measures of location such as medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery |
| Timed up and go test after six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery |
| Timed up and go test after three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery |
| Timed up and go test after six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery |
| Timed up and go test after 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery |
| Opioid consumption and osteoporosis medication in the last six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery |
| Opioid consumption and osteoporosis medication in the last three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery |
| Opioid consumption and osteoporosis medication in the last six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery |
| Opioid consumption and osteoporosis medication in the last 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery |
| Change in quality of life measured by the EuroQol-5D-3L after six weeks. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six weeks after surgery |
| Change in quality of life measured by the EuroQol-5D-3L after three months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time three months after surgery |
| Change in quality of life measured by the EuroQol-5D-3L after six months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time six months after surgery |
| Change in quality of life measured by the EuroQol-5D-3L after 12 months. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. Appropriate significance tests will be applied. | Time 12 months after surgery |
| Proportion of screws or iFuse fractures. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months |
| Proportion of screw sintering. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months |
| Proportion of sintering/migration of the iFuse implant. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months |
| Proportion of radiological signs of loosening. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months |
| Proportion of infections. | Appropriate measures of location such as frequencies/percentages or medians/quartiles are calculated. If necessary, appropriate significance tests are applied. | Time within 12 months |
| Mainz |
| 55131 |
| Germany |
| Helios Universitätsklinikum Wuppertal | Wuppertal | 42283 | Germany |
| 26319676 | Background | Kannus P, Parkkari J, Niemi S, Sievanen H. Low-Trauma Pelvic Fractures in Elderly Finns in 1970-2013. Calcif Tissue Int. 2015 Dec;97(6):577-80. doi: 10.1007/s00223-015-0056-8. Epub 2015 Aug 29. |
| 24419459 | Background | Nanninga GL, de Leur K, Panneman MJ, van der Elst M, Hartholt KA. Increasing rates of pelvic fractures among older adults: The Netherlands, 1986-2011. Age Ageing. 2014 Sep;43(5):648-53. doi: 10.1093/ageing/aft212. Epub 2014 Jan 12. |
| 26418971 | Background | Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, Grebe J, Vogt A, Jungbluth P, Rosler G, Windolf J, Icks A. Epidemiology of Pelvic Fractures in Germany: Considerably High Incidence Rates among Older People. PLoS One. 2015 Sep 29;10(9):e0139078. doi: 10.1371/journal.pone.0139078. eCollection 2015. |
| 27448040 | Background | Maier GS, Kolbow K, Lazovic D, Horas K, Roth KE, Seeger JB, Maus U. Risk factors for pelvic insufficiency fractures and outcome after conservative therapy. Arch Gerontol Geriatr. 2016 Nov-Dec;67:80-5. doi: 10.1016/j.archger.2016.06.020. Epub 2016 Jul 15. |
| 28359073 | Background | Rommens PM, Wagner D, Hofmann A. Fragility Fractures of the Pelvis. JBJS Rev. 2017 Mar 21;5(3):e3. doi: 10.2106/JBJS.RVW.16.00057. No abstract available. |
| 27077891 | Background | Breuil V, Roux CH, Carle GF. Pelvic fractures: epidemiology, consequences, and medical management. Curr Opin Rheumatol. 2016 Jul;28(4):442-7. doi: 10.1097/BOR.0000000000000293. |
| 21513936 | Background | Pohlemann T, Stengel D, Tosounidis G, Reilmann H, Stuby F, Stockle U, Seekamp A, Schmal H, Thannheimer A, Holmenschlager F, Gansslen A, Rommens PM, Fuchs T, Baumgartel F, Marintschev I, Krischak G, Wunder S, Tscherne H, Culemann U. Survival trends and predictors of mortality in severe pelvic trauma: estimates from the German Pelvic Trauma Registry Initiative. Injury. 2011 Oct;42(10):997-1002. doi: 10.1016/j.injury.2011.03.053. Epub 2011 Apr 22. |
| 28272751 | Background | Andrich S, Haastert B, Neuhaus E, Neidert K, Arend W, Ohmann C, Grebe J, Vogt A, Jungbluth P, Thelen S, Windolf J, Icks A. Excess Mortality After Pelvic Fractures Among Older People. J Bone Miner Res. 2017 Sep;32(9):1789-1801. doi: 10.1002/jbmr.3116. Epub 2017 May 8. |
| 34844577 | Background | Ullrich BW, Schnake KJ, Spiegl UJA, Schenk P, Mendel T, Behr L, Bula P, Flucht LB, Franck A, Gercek E, Gruninger S, Hartung P, Jacobs C, Katscher S, Klauke F, Liepold K, Muller CW, Muller M, Osterhoff G, Partenheimer A, Piltz S, Riehle M, Sauer D, Scheyerer MJ, Schleicher P, Schmeiser G, Schmidt R, Scholz M, Siekmann H, Sprengel K, Stoevesandt D, Verheyden A, Zimmermann V; Spine Section of the German Society for Orthopaedics and Trauma. OF-Pelvis classification of osteoporotic sacral and pelvic ring fractures. BMC Musculoskelet Disord. 2021 Nov 29;22(1):992. doi: 10.1186/s12891-021-04882-6. |
| 23178479 | Background | Hammer N, Lingslebe U, Aust G, Milani TL, Hadrich C, Steinke H. Ultimate stress and age-dependent deformation characteristics of the iliotibial tract. J Mech Behav Biomed Mater. 2012 Dec;16:81-6. doi: 10.1016/j.jmbbm.2012.04.025. Epub 2012 Oct 30. |
| D007869 |
| Leg Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |