LOQTEQ® Antibacterial Pre-Market Study

Launched by AAP IMPLANTATE AG · Feb 18, 2022

Keywords

ClinConnect Summary

The LOQTEQ® Antibacterial Pre-Market Study is a clinical trial that is looking at the safety of a special antibacterial system designed for patients with fractures, particularly those involving the fibula (the smaller bone in your lower leg). This study compares the new silver-coated LOQTEQ® system, which is supposed to help prevent infections, to the regular, uncoated version of the LOQTEQ® system. The goal is to see if the silver-coated version is just as safe as the one without the coating.

To be eligible for this study, participants need to be at least 18 years old and have a fracture of the distal fibula. They should also be able to give written consent to join the study. However, some people may not be able to participate, such as those with certain medical conditions, allergies to silver, or those who are pregnant or breastfeeding. If someone chooses to participate, they can expect to be part of a randomized study where they will receive either the new silver-coated device or the standard one, and their progress will be monitored to ensure their safety throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
• • 2. Subject aged 18 years and over.
• • 3. Subjects with fractures of the distal fibula.
• Exclusion Criteria:
• • 1. Subject unable to give written informed consent, is unlikely to cooperate or is legally incompetent.
• • 2. Subjects with consumptive / malignant primary disease and a life expectancy of less than 12 months.
• • 3. Subjects with a known allergy to silver or any components of the device.
• • 4. Subjects with an already implanted silver-coated device other than the investigational device.
• • 5. History of or ongoing chronic soft-tissue and/or bone and/or implant infection signs at the distal tibia and/or distal fibula (not related to current fracture).
• • 6. Subjects with a possible contraindication for the investigational and comparator devices
• • 1. infection or inflammation requiring treatment with antibiotics or with positive cultures (not related to current fracture);
• • 2. acute and chronic osteomyelitis at or close to the surgical field (not related to current fracture);
• • 3. high anesthesia risk subjects (ASA Physical Status Classification of 4 to 6);
• • 4. subjects with neurological disorders who cannot follow instructions given by their physician;
• • 5. subjects with past history of severe medical disorders of extremity which may impact study device efficacy and safety according to investigator\'s judgment;
• • 6. severe chronic or acute comorbidity according to investigator's judgement (such as arthritis or neurogenic disorders).
• • 7. Female subjects who are pregnant or lactating at Screening Visit.
• • 8. Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions according to investigator's judgement can be included.
• • 9. Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study. Males who are unable or unwilling to use condoms can be included if partners of childbearing potential taking acceptable contraceptive precautions according to investigator's judgement.
• • 10. Participation in any other study involving an investigational drug or device currently or within the past 3 months.
• • 11. Subject has a significant history of drug/solvent abuse.
• • 12. Subject has a history of alcohol abuse or currently drinks more than 224 g alcohol for men and 112 g alcohol for women per week.
• • 13. Subjects with stage IV vascular disease, i.e. with presence of necrotic tissue at the distal tibia.