An observational study in Distal Femur Fracture, Periprosthetic Fractures and Intra-Articular Fractures, sponsored by 41medical AG. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by 41medical AG · Observational
The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.
The goal of this observational study is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care. The study is conducted as a retrospective and prospective multicenter case series. Eligible patients are those with fractures of the distal femur who are treated with the Biphasic Plate DF according to the Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months, whichever comes first.
To assess the safety and performance following data is collected:
31 studies on the registry are indexed under Femoral Fractures, Distal; 11 are open to participants now.
Browse Femoral Fractures, Distal studies →This is the only study on the registry with 41medical AG as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Eledgible patients will be identified at the sites (primary care clinics)
Inclusion Criteria:
Patients with fractures of the distal femur requiring internal fixation and treated with the Biphasic Plate DF as indicated according to the IFU. As per the IFU, the Biphasic Plate DF is indicated for:
Exclusion Criteria (preoperatively):
Exclusion Criteria (intraoperatively):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Occurrence of AEs/SAEs in the affected lower extremity/extremities
The primary outcome measure is the occurrence of AEs/SAEs in the affected lower extremity/extremities that are deemed related, probably related, or possibly related to the surgical procedure or the Biphasic Plate DF
Time frame: until clinically healed or up to 12 months
Bone Healing
Radiographic bone healing assessment using the modified Radiographic Union Scale for Tibia (mRUST) Score (1: Callus absent, visible fracture line, 2: Callus present, visible fracture line, 3: Callus bridging, visible fracture line, 4: Callus remodeled, invisible fracture line) Bone healing as assessed by the surgeon
Time frame: until clinically healed or up to 12 months
Patient-reported outcome measures
Quality of life questionaire Pain NRS (0-10) upon weightbearing
Time frame: until clinically healed or up to 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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