BridgeMD
New treatment option for Femoral Fracture
Official title Fracture Monitor - Femur
ClinicalTrials.gov ID: NCT05410587
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Homburg, Germany
- Münster, Germany
- Tübingen, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homburg, Germany; Münster, Germany; Tübingen, Germany; Ulm, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.