Safety and Performance of the Biphasic Plate Distal Femur... | NCT06028971

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

NCT06028971

Sponsor

41medical AG

Status

Active, not recruiting

Last Update Posted

Jul 10, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Distal Femur Fracture
Periprosthetic Fractures
Intra-Articular Fractures
Supracondylar Fracture

Interventions

Not provided

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 29, 2024Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Oct 31, 2027Estimated

First Submitted Date

Sep 1, 2023

First Submission Date that Met QC Criteria

Sep 1, 2023

First Posted Date

Sep 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2025

Last Update Posted Date

Jul 10, 2025Actual

Name	Class
AO Innovation Translation Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	until clinically healed or up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
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	until clinically healed or up to 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Christoph Sommer, Dr. med.	Kantonsspital Graubünden Chur	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Univeritätsklinikum Münster		Münster	North Rhine-Westphalia	48149	Germany
Diakonie Jung-Stilling Siegen

Condition Browse Module

MeSH Terms

ID	Term
D000092524	Femoral Fractures, Distal
D057068	Periprosthetic Fractures
D057072	Intra-Articular Fractures
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided