Status:
RECRUITING
Fracture Monitor - Femur
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Femoral Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 atta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05410587
Start Date
October 3 2023
End Date
July 1 2026
Last Update
February 3 2025
Active Locations (4)
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1
Universitätsklinikum des Saarlandes
Homburg, Germany
2
Universitätsklinikum Münster
Münster, Germany
3
Berufsgenossenschaftliche Unfallklinik Tübingen
Tübingen, Germany
4
Universitätsklinikum Ulm
Ulm, Germany