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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05367505
Other study ID # TIKTIS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date December 1, 2026

Study information

Verified date May 2024
Source University of Witten/Herdecke
Contact Katharina Graf
Phone +49 202 896
Email katharina.graf@uni-wh.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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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Study Design


Intervention

Device:
iFuse-3D implant
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.

Locations

Country Name City State
Germany Diakonie Krankenhaus Bad Kreuznach
Germany University Medical Center of the Johannes Gutenberg University Mainz Mainz
Germany Helios Universitätsklinikum Wuppertal Wuppertal

Sponsors (3)

Lead Sponsor Collaborator
University of Witten/Herdecke Johannes Gutenberg University Mainz, SI-BONE, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Proportion of patients who achieve pre-fracture mobility at three months. The proportion is shown with frequencies and corresponding percentages. Time three months after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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