Z47.0
Conditions
Interventions
Group 1: The course of the intervention in the clinical investigation will follow the standard procedure as routinely performed at the Investigational Site – basically without the use of an auxiliary
Sponsors
susatu GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Preceding treatment with osteosynthesis material in terms of free implanted screws • Indication for removal of the free implanted screws after fracture healing based on the assessment of the treating physician • Free implanted screw to be removed is located in the area of the foot/ankle joint or knee • Screw type and condition identifiable before the intervention Screw size and type covered by the intended use of the susatu PHOENIX Metal Detector • Patient has no implanted active medical devices • Patient has an age =18 years at time of consent • Patient is not pregnant or breastfeeding • Patient has no documented alcohol or drug abuse • Patient is not an employee of the Investigational Site, with direct involvement in this trial or other trials under the direction of the Investigational Site, as well as not a family member of the investigators • Patient is not a prisoner • Patient has been adequately informed of risks and requirements of the trial and written informed consent is provided • Patient was not participating in any other trial involving investigational drugs or devices within 4 weeks prior to screening and patient must agree not to participate in any other clinical trial at the same time and not for a period of 1 month after the SPOT Trial Delayed identifiable inclusion criterion: • Screw head not directly recognisable after standard surgical preparation due to overgrowth of bone material or connective tissue
Exclusion criteria
Exclusion criteria: • Patient is unwilling or unable to comply with trial requirements • Patients who met all inclusion criteria but had changes that affected at least one inclusion criterion before the procedure was performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the time duration ZEIT between the moment the surgeon picks up the susatu PHOENIX Metal Detector – following the completion of site preparation – and the successful detection of the screw head. (Evidence of the device’s clinical performance is obtained by comparing ZEIT with a predefined standard value.) | — |
Countries
Switzerland
Contacts
Public ContactMichael Schär
Inselspital, Universitätsspital Bern Universitätsklinik für Orthopädische Chirurgie und Traumatologie
Outcome results
None listed