LOQTEQ® Antibacterial Pre-Market Study

NCT05260463 | Completed

• 1 other identifier: aap001
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

Silver-coating; antibacterial; Fibula; Orthopaedic

Outcome Measures

Primary Outcomes (1)

• Anticipated Adverse Device Effect (AADE)

  The primary endpoint for this study is the proportion of subjects with at least one predefined Anticipated Adverse Device Effect (AADE) within 12 months of implantation.

  Implantation until 12 months follow-up

Secondary Outcomes (10)

• Proportion of subjects with device related infections

  Implantation until 12 months follow-up

• Radiographic (X-ray) fracture healing

  Implantation until 12 months follow-up

• Hospitalization and nights spent in hospital

  Implantation until 12 months follow-up

• Change in Ankle-Hindfoot Score (AOFAS)

  Implantation until 12 months follow-up

• Change in Average Pain at Rest (VAS)

  Implantation until 12 months follow-up

Study Arms (2)

Silver-coated Implant

EXPERIMENTAL

The summary description and intended purpose of the investigational device (LOQTEQ® antibacterial silver-coated system) is the same as that of the comparator device (LOQTEQ® 3.5 System (uncoated) system). The investigational device differs from the comparator device in that its surface which has been modified by the addition of an antibacterial coating.

Device: Implantation

Uncoated Implant

ACTIVE COMPARATOR

The summary description and intended purpose of the investigational device (LOQTEQ® antibacterial silver-coated system) is the same as that of the comparator device (LOQTEQ® 3.5 System (uncoated) system) and differes only in the lack of the antibacterial coating.

Device: Implantation

Interventions

Implantation DEVICE

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

Silver-coated Implant; Uncoated Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• high anesthesia risk subjects (ASA Physical Status Classification of 4 to 6);
• subjects with neurological disorders who cannot follow instructions given by their physician;
• subjects with past history of severe medical disorders of extremity which may impact study device efficacy and safety according to investigator\'s judgment;
• severe chronic or acute comorbidity according to investigator's judgement (such as arthritis or neurogenic disorders).
• Female subjects who are pregnant or lactating at Screening Visit.
• 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.
• 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.

Sponsors & Collaborators

• aap Implantate AG: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (13)

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93042, Germany

Location

Unfallkrankenhaus Berlin

Berlin, 12683, Germany

Location

Helios Klinikum Berlin-Buch GmbH

Berlin, 13125, Germany

Location

Städtisches Klinikum Dresden

Dresden, 01067, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Gießen-Marburg

Giessen, 35385, Germany

Location

Universitätsklinikum Homburg-Saar

Homburg, 66421, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum Rostock

Rostock, Germany

Location

Agaplesion Bethesda Krankenhaus Wuppertal

Wuppertal, 42109, Germany

Location

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

Location

Related Publications (1)

• Schoder S, Lafuente M, Alt V. Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study. Trials. 2022 Dec 1;23(1):968. doi: 10.1186/s13063-022-06919-0.

  PMID: 36456987 DERIVED

MeSH Terms

Conditions

Fractures, Open; Fractures, Closed; Surgical Wound Infection; Fibula Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Volker Alt, Prof. Dr.

  Universitätsklinikum Regensburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 2, 2022
• Study Start: December 9, 2021
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: September 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13)