NCT05260463

LOQTEQ® Antibacterial Pre-Market Study

LOQTEQ® Antibacterial Pre-Market Study Randomized, Controlled, Subject-blinded, Multi-center Study of LOQTEQ® Antibacterial Locking Plates in Subjects With Fractures of the Distal Fibula

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: aap Implantate AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 184 patients. A number of 92 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Implantation	Fractures of the distal fibula are treated with a trauma implant.

Timeline

• Start date: 2021-12-09
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2022-03-02
• Last updated: 2025-09-18

Locations

13 sites across 1 country: Germany