Fracture of Distal End of Radius
Conditions
Brief summary
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery. Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
Interventions
PROCEDURETreatment with investigational method (virtual implant positioning system)
PROCEDURETreatment with surgical standard of care
Sponsors
Siemens Healthcare QT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with diastal fracture of the radius * Patients with the mentioned fracture and indication for surgical treatment according to national guidelines * Age \>/= 18 years of age * Patients willing to participate and after having given their informed consent in written form
Exclusion criteria
* Participation in other interventional clinical trials * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of screw replacements in both treatments arms | Participants will be followed for the duration of the hospital stay, an expected average of 3 days | The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B) |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the investigational method to the standard of care regarding radiation time. | Participants will be followed for the duration of the hospital stay, an expected average of 3 days |
| Number of adverse events and serious adverse events during the clinical investigarion. | Participants will be followed for the duration of the hospital stay, an expected average of 3 days |
Countries
Germany
Outcome results
None listed