Assessing the safety and performance of a new plate for distal femur fractures
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
This study is testing a new plate for fixing thigh bone fractures to see how safe it is and how well it helps people heal and feel better over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | 41medical AG Industry-sponsored |
| Locations | 5 sites (Münster, Nordrhein-Westfalen and 4 other locations) |
| Trial ID | NCT06028971 on ClinicalTrials.gov |
What this trial studies
This observational multicenter case series aims to evaluate the safety and performance of the CE-marked 'Biphasic Plate Distal Femur' in patients with distal femur fractures. The study includes both retrospective and prospective data collection from patients treated with this device according to the Instruction for Use. Participants will be monitored for adverse events, bone healing, weightbearing, function, quality of life, and pain levels for up to 12 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with specific types of distal femur fractures requiring internal fixation.
Not a fit: Patients participating in another interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with distal femur fractures by providing evidence for the effectiveness of the Biphasic Plate DF.
How similar studies have performed: Similar studies assessing innovative fixation devices have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Münster, Nordrhein-Westfalen and 4 other locations
- Univeritätsklinikum Münster — Münster, Nordrhein-Westfalen, Germany (Recruiting)
- Diakonie Jung-Stilling Siegen — Siegen, Nordrhein-Westfalen, Germany (Recruiting)
- Kantonsspital Graubünden — Chur, Graubünden, Switzerland (Recruiting)
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Universitätsspital Zürich — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christoph Sommer, Dr. med. — Kantonsspital Graubünden Chur
- Study coordinator: Marcel Aeschlimann
- Email: clinicaltrials@41medical.com
- Phone: +41 32 645 41 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.