Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series

41medical

Status: Active, not recruiting

Conditions: Intra-Articular Fractures; Periprosthetic Fractures; Supracondylar Fracture; Distal Femur Fracture

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06028971

1156

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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