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Safety and performance of the biphasic plate distal femur: a multicenter case series

NCT ID NCT06028971

NEW Sponsor: 41medical AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eledgible patients will be identified at the sites (primary care clinics)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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. * 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 Exclusion Criteria (preoperatively): * Patient is participating in another interventional clinical trial. Exclusion Criteria (intraoperatively): * 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

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Conditions

The condition(s) this trial relates to.

Femoral Fractures Femoral Fractures, Distal Intra-Articular Fractures Periprosthetic Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Distal femur fracture Intra-articular fractures Periprosthetic fractures Supracondylar fracture

Contacts and locations

Locations

  • Diakonie Jung-Stilling Siegen

    Siegen, North Rhine-Westphalia, 57074, Germany

  • Kantonsspital Graubünden

    Chur, Kanton Graubünden, 7000, Switzerland

  • Univeritätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Universitätsspital Zürich

    Zurich, Canton of Zurich, 8091, Switzerland

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