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LOQTEQ® Antibacterial Pre-Market Study

NCT05260463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2025-09-18

No results posted yet for this study

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

Conditions

  • Fractures, Open
  • Fractures, Closed
  • Surgical Site Infection
  • Fracture of Fibula

Interventions

DEVICE

Implantation

Fractures of the distal fibula are treated with a trauma implant.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • aap Implantate AG

    lead INDUSTRY

Principal Investigators

  • Volker Alt, Prof. Dr. · Universitätsklinikum Regensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2025-08-04
Completion
2025-08-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260463 on ClinicalTrials.gov