LOQTEQ® Antibacterial Pre-Market Study

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Antimicrobial coatings of implants are of interest to reduce infection rate in orthopaedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evaluate the clinical performance of a silver-coating for locking plates for fracture treatment. The study design has to respect different criteria, such as feasibility, focus on overall complications, such as functional impairment, fracture healing and infection rates. The study design was defined as randomized, controlled, subject-blinded, multi-center study in subjects with fractures of the distal fibula with a total of 254 patients. A number of 127 patients are planned for each of the two treatment arms with treatment of the fracture with a silver-coated device (first arm) or with an uncoated device (second arm). Inclusion criteria are closed and open fractures of the distal fibula with Gustilo-Anderson type I to Gustilo-Anderson type IIIB type older than 18 years. Primary outcome parameter is the Anticipated Adverse Device Effects (AADE) including all typical complications of this type of injury, such as functional impairment of the affected limb, non-union and infections based on a non-inferiority study design. Also, silver-typical complications, such as argyria, are included. Secondary parameters are infection rates and fracture healing. Follow-up of patients includes five visits with clinical and X-ray evaluations with a follow-up time of 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05260463
Study type	Interventional
Source	aap Implantate AG
Contact	Stefan Schoder, Dr.
Phone	+49.30.75019-052
Email	s.schoder@aap.de
Status	Recruiting
Phase	N/A
Start date	December 9, 2021
Completion date	December 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.