Clinical trial NCT06028971: Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
Official title: Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: 41medical AG
Sponsor class: INDUSTRY
Collaborators: name: AO Innovation Translation Center
First posted: 2023-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eledgible patients will be identified at the sites (primary care clinics)

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of AEs/SAEs in the affected lower extremity/extremities
timeFrame: until clinically healed or up to 12 months
Secondary outcomes:
measure: Bone Healing
timeFrame: until clinically healed or up to 12 months
measure: Patient-reported outcome measures
timeFrame: until clinically healed or up to 12 months
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Univeritätsklinikum Münster
state: Nordrhein-Westfalen
city: Siegen
country: Germany
facility: Diakonie Jung-Stilling Siegen
state: Nordrhein-Westfalen
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: Graubünden
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Kantonsspital Graubünden Chur
name: Christoph Sommer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: