Distal Femur FractureNCT06028971
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
An observational study of Distal Femur Fracture and Periprosthetic Fractures, run by 41medical AG at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 29 Feb 2024to 31 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eledgible patients will be identified at the sites (primary care clinics)
Who may be able to join
- 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:
- Distal shaft fractures
- Supracondylar fractures
- Intraarticular fractures
- Periprosthetic fractures
- No other major implant beside the Biphasic Plate DF is used for fixation of the distal femur fracture, with the exceptions of lag screw(s) and/or cerclage wire(s), and/or a joint replacement.
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- Patients who are willing and able to comply with postoperative FUs per local standard of care.
- Ability to provide informed consent according to the IRB/EC defined and approved procedures.
- Patients over 18 years of age
Who cannot join
- Patient is participating in another interventional clinical trial.
- Change of surgical plan intraoperatively at the discretion of the surgeon that Biphasic Plate DF is not used
- Necessity to apply a second (medial) plate (double plating) or an intramedullary nail in case of critical fixation distally
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Switzerland3 sites
Universitätsspital Basel
Basel, 4031
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Universitätsspital Zürich
Zurich, Canton of Zurich, 8091
Germany2 sites
Univeritätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Diakonie Jung-Stilling Siegen
Siegen, North Rhine-Westphalia, 57074
About this study
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.
Read the detailed description
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:
- incidents of AEs/SAEs occurring in the affected lower extremity/extremities
- Bone healing assessed by a surgeon
- Weightbearing and function
- Patients' quality of life and pain level
- Conditions
- Distal Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures, Supracondylar Fracture
- Keywords
- Biphasic Plate DF, Distal Femur Fracture, Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures
- Medical subject headings
- Femoral Fractures, Distal, Periprosthetic Fractures, Intra-Articular Fractures, Femoral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: until clinically healed or up to 12 months
Secondary outcomes (2)
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
Measured: until clinically healed or up to 12 months
Patient-reported outcome measures
Quality of life questionaire Pain NRS (0-10) upon weightbearing
Measured: until clinically healed or up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start29 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 41medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AO Innovation Translation Center
- Responsible party
- Sponsor
- Investigators
- Christoph Sommer, Dr. med., Principal investigator, Kantonsspital Graubünden Chur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028971
- Sponsor's protocol ID
- 1156
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No