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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Diakonie Krankenhaus
Bad Kreuznach, Germany
RECRUITINGUniversity Medical Center of the Johannes Gutenberg University Mainz
Mainz, Germany
NOT_YET_RECRUITINGHelios Universitätsklinikum Wuppertal
Wuppertal, Germany
RECRUITINGProportion 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 frame: Time 8 days (discharge) after surgery
Proportion of patients who achieve pre-fracture mobility within six weeks.
The proportion is shown with frequencies and corresponding percentages.
Time frame: Time six weeks after surgery
Proportion of patients who achieve pre-fracture mobility at three months.
The proportion is shown with frequencies and corresponding percentages.
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time within 12 months
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