Monitoring femoral fracture healing with a device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter interventional study involves 37 patients with femoral fractures who will receive treatment using a compatible locking plate. An implantable device, the Fracture Monitor T1, will be attached during surgery to continuously collect data on the healing process. Patients will use a smartphone app to facilitate data transfer to a secure cloud server, although the data will remain inaccessible to both patients and surgeons during rehabilitation to avoid influencing treatment decisions. The study aims to gather valuable information on fracture healing while adhering to standard care protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Closed growth plates at time of injury
* Femoral fracture requiring osteosynthesis and treated with one of the following plates:

  * DePuy Synthes LCP® 4.5/5, Broad
  * DePuy Synthes LCP® 4.5/5, Broad Curved
  * DePuy Synthes LCP® Condylar Plate 4.5/5.0
  * DePuy Synthes VA-LCP® Condylar Plate 4.5/5.0
  * DePuy Synthes LCP® Distal Femur
  * DePuy Synthes LCP® Proximal Femoral Plate 4.5/5.0
  * DePuy Synthes LCP® Proximal Femur Hook Plate
  * 41medical AG, Biphasic Plate DF
* ASA score 1-3
* Full weight-bearing capacity prior to the injury
* The patient is foreseen to be capable of postoperative weight bearing of at least 15 kg
* Willingness to undergo an additional surgery to remove the Fracture Monitor T1 if its removal is not done together with the fixation plate within two years according to standard of care
* Ability to provide written informed consent

Preoperative exclusion Criteria:

* Concomitant fractures in the contralateral leg
* Electromagnetic hypersensitivity
* Implanted electromagnetic bone stimulators
* Pregnancy (determined by pregnancy test)
* Prisoner
* Known history of substance abuse (eg, recreational drugs and alcohol) that would preclude reliable assessments
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present clinical investigation

Intraoperative exclusion criteria:

* Use of compression lag screw across fracture fragment
* Compression osteosynthesis
* Precontouring of implant at the area of the attachment of Fracture Monitor T1
* Double-plating technique
* Soft-tissue coverage \> 6 cm above the data logger
* Concurrent use of intramedullary nail
* Patients foreseen to require magnetic resonance imaging scanning at any part of the body or shockwave therapy at the proximity of the Fracture Monitor T1
* Fracture Monitor T1 not functional according to the instruction for use (IFU, section 24, A) and no functional replacement implant available

Where it's running

• Universitätsklinikum des Saarlandes
  Homburg, Germany Recruiting
• Universitätsklinikum Münster
  Münster, Germany Recruiting
• Berufsgenossenschaftliche Unfallklinik Tübingen
  Tübingen, Germany Recruiting
• Universitätsklinikum Ulm
  Ulm, Germany Recruiting

Study contacts

• Principal investigator: Benedikt Braun — University Hospital Tuebingen
• Study coordinator: Viola Grünenfelder
• Email: viola.gruenenfelder@aofoundation.org
• Phone: +41 79 696 33 97

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.