Fracture Monitor - Femur

Official title

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

Overview

Thirty-seven patients diagnosed with femoral fracture to be treated with a compatible plate will be enrolled for this multicenter prospective interventional study. The Fracture Monitor T1 will be attached to the locking plate during osteosynthesis. Prior to discharge, it will be connected to an app installed either on the patients' smartphone or on the smartphone provided by the sponsor. The device will continuously collect and process data, which can automatically be downloaded via Bluetooth through the smartphone app and transferred in encrypted form to a dedicated cloud server. The smartphones will be equipped with a basic app version with rudimentary user interface that has no data visualization function. During the rehabilitation phase, data collected by the device will not be accessible to the surgeon nor the patient to ensure that no therapeutic decision will be made based on the acquired data. Every patient is treated as per standard of care. The primary objective of the study is to collect safety information of the Fracture Monitor T1. The secondary objectives are to collect information on device performance, device handling, and usability. All adverse events (AEs) and serious AEs (SAEs) will be recorded during the study. These will be reviewed and evaluated for their potential relationship to the device. All patients will be followed up for 6 months after the surgery according to the local standard of care. Given that the removal of the Fracture Monitor T1 may occur beyond 6 months, a safety follow-up will take place at the time point when the Fracture Monitor T1 is removed as per the instructions for use if it has not been removed within the 6 months. The results will be compiled into a clinical evaluation report to be submitted as part of the technical documentation for the conformity assessment procedure.

Interventions

• Device Fracture Monitor (implantable device class III)
  Femoral fracture fixation (bridge plating aiming at secondary bone healing) using a locking plate with an attached investigational Fracture Monitor T1.

Primary outcome measures

• Incidence of ADEs [Time frame: 6 months postsurgery]

Secondary outcome measures (12)

• Clinical performance: Relationship - implant load/bone healing [Time frame: 6 months]
• Clinical performance: Relationship - implant load/weight bearing [Time frame: 6 months]
• Clinical performance: Relationship - implant load/Function Index for Trauma(FIX-IT) [Time frame: 6 months]
• Clinical performance: Relationship - implant load/Patient reported outcomes [Time frame: 6 months]
• Clinical performance: Relationship - implant load/Modified Radiographic union score for tibia(mRUST) [Time frame: 6 months]
• Clinical performance: Curve drop [Time frame: 6 months]
• Clinical performance: Difference curve drop/soc x-ray [Time frame: 6 months]
• Other safety parameters: AEs [Time frame: 6 months]
• Other safety parameters: DD [Time frame: 6 months]
• Technical performance in a clinical setup [Time frame: 6 months]
• Technical performance in a clinical setup [Time frame: 6 months]
• Technical performance in a clinical setup [Time frame: 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 4 centers

• Universitätsklinikum des Saarlandes — Homburg
• Universitätsklinikum Münster — Münster
• Berufsgenossenschaftliche Unfallklinik Tübingen — Tübingen
• Universitätsklinikum Ulm — Ulm

Publications

• Braun BJ, Raschke MJ, Schutze K, Pohlemann T, Joeris A, Ernst M. 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: a study protocol. BMJ Open. 2025 Jul 30;15(7):e102749. doi: 10.1136/bmjopen-2025-102749. PMID 40744509

Identifiers

NCT: NCT05410587 · FM_AO_001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗