“Safety and performance of the biphasic plate for the distal femur: A multicenter case series”
Summary description of the study
The treatment of distal femur fractures can be challenging and may involve many complications. For this reason, the sponsor of this study has developed a new type of implant, the biphasic plate DF, for the fixation of the fracture. This new device is designed to reduce complications and allow the patient to load the fracture earlier. The aim of this study is to collect data on the use of the biphasic plate DF regarding the safety of application and the performance of the implant. Your participation in this study will last for one year or until clinical healing of the fracture - whichever occurs first. You will be treated according to local treatment standards. Data on standard treatment will be collected in the study. The only collected data that may not be part of standard treatment consists of a questionnaire in which you will be asked about your quality of life and your pain on a scale from 0 to 10.
(BASEC)
Intervention under investigation
The biphasic plate DF, for fixation of a femur fracture.
(BASEC)
Disease under investigation
You have either undergone implantation of a biphasic plate DF due to a femur fracture, or such surgery is planned.
(BASEC)
- Patients aged over 18 years - Patients with distal femur fractures requiring internal fixation and treated with the biphasic plate DF. - Patients who are willing and able to comply with postoperative follow-up visits according to local treatment standards. (BASEC)
Exclusion criteria
- The patient is participating in another clinical intervention study. - Need for application of an additional (medial/ventral) plate (double plating) or an intramedullary nail. (BASEC)
Trial sites
Basel, Chur, Zurich
(BASEC)
Sponsor
41medical AG
(BASEC)
Contact
Contact Person Switzerland
Marcel Aeschlimann
+41 32 645 41 41
clinicaltrials@clutter41medical.com41medical AG
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
23.01.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Safety and performance of the Biphasic Plate Distal Femur: A multicenter case series (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available