Monitoring femoral fracture healing with a device
Prospective First in Human Clinical Investigation to Evaluate the Safety of the Fracture Monitor T1 in Patients with Femur Fractures Treated with a Locking Compression Plate
This study is testing a new device that helps track how well femoral fractures heal in patients using a special locking plate and a smartphone app.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AO Innovation Translation Center Academic / other |
| Locations | 4 sites (Homburg and 3 other locations) |
| Trial ID | NCT05410587 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a femoral fracture requiring surgical fixation and who meet specific health criteria.
Not a fit: Patients with concomitant fractures in the contralateral leg will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of femoral fracture healing and improve postoperative care.
How similar studies have performed: While the use of monitoring devices in fracture healing is gaining interest, this specific approach appears to be novel and untested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Homburg and 3 other locations
- 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 Tübingen
- Study coordinator: Viola Grünenfelder
- Email: viola.gruenenfelder@aofoundation.org
- Phone: +41 79 696 33 97
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.