CompletedNot Applicable

LOQTEQ® Antibacterial Pre-Market Study

Germany203 participantsStarted 2021-12-09

Plain-language summary

aap001 is a randomized, controlled, subject-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
✓. Subject aged 18 years and over.
✓. Subjects with fractures of the distal fibula.

Exclusion criteria

✕. Subject unable to give written informed consent, is unlikely to cooperate or is legally incompetent.
✕. Subjects with consumptive / malignant primary disease and a life expectancy of less than 12 months.
✕. Subjects with a known allergy to silver or any components of the device.
✕. Subjects with an already implanted silver-coated device other than the investigational device.
✕. 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).
✕. Subjects with a possible contraindication for the investigational and comparator devices
✕. infection or inflammation requiring treatment with antibiotics or with positive cultures (not related to current fracture);
✕. acute and chronic osteomyelitis at or close to the surgical field (not related to current fracture);

What they're measuring

Anticipated Adverse Device Effect (AADE)

Timeframe: Implantation until 12 months follow-up

Trial details

NCT IDNCT05260463

Sponsoraap Implantate AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-04

View on ClinicalTrials.gov More Fractures, Open trials