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Fractures, OpenNCT05260463

LOQTEQ® Antibacterial Pre-Market Study

A study testing Implantation in people with Fractures, Open and Fractures, Closed, run by aap Implantate AG at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
13 sitesGermany
Study dates
9 Dec 2021to 4 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.
  • Participation in any other study involving an investigational drug or device currently or within the past 3 months.
  • Subject has a significant history of drug/solvent abuse.
  • Subject has a history of alcohol abuse or currently drinks more than 224 g alcohol for men and 112 g alcohol for women per week.
  • Subjects with stage IV vascular disease, i.e. with presence of necrotic tissue at the distal tibia.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Helios Klinikum Berlin-Buch GmbH

    Berlin, 13125

  • Städtisches Klinikum Dresden

    Dresden, 01067

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen-Marburg

    Giessen, 35385

  • Universitätsklinikum Homburg-Saar

    Homburg, 66421

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93042

  • Universitätsklinikum Rostock

    Rostock

  • Agaplesion Bethesda Krankenhaus Wuppertal

    Wuppertal, 42109

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

About this study

Official title: 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

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

Read the 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.

Being tested
Implantation
Keywords
Silver-coating, antibacterial, Fibula, Orthopaedic
Medical subject headings
Fractures, Open, Fractures, Closed, Surgical Wound Infection, Fibula Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImplantationDevice

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

Study groups in NCT05260463
Study groupRoleWhat they receive
Silver-coated ImplantExperimentalThe 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.
Receives: Device: Implantation
Uncoated ImplantActive comparatorThe 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.
Receives: Device: Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Implantation until 12 months follow-up

Secondary outcomes (10)

  1. Proportion of subjects with device related infections

    Investigate the proportion of subjects with device-related infections occurring after successful implantation of study device and end of the 12-month FU and compare the rate between treatment arms.

    Measured: Implantation until 12 months follow-up

  2. Radiographic (X-ray) fracture healing

    Investigate fracture healing assessed by local and central reviewer and compare the rate of completely healed subjects between treatment arms.

    Measured: Implantation until 12 months follow-up

  3. Hospitalization and nights spent in hospital

    Investigate the number of hospitalizations occurring in the first 12 months post-implantation and the nights spent in hospital and compare the numbers between treatment arms.

    Measured: Implantation until 12 months follow-up

  4. Change in Ankle-Hindfoot Score (AOFAS)

    Investigate the change in AOFAS at each FU visit and compare endpoint between the treatment arms. The change is defined as the difference between AOFAS at the respective FU and the AOFAS at the 1-week FU.

    Measured: Implantation until 12 months follow-up

  5. Change in Average Pain at Rest (VAS)

    Investigate the change in average pain at rest at each FU visit and compare endpoint between the treatment arms. The Change in Average Pain is defined as the difference between VAS value at the respective FU and the AOFAS at the 1-week FU.

    Measured: Implantation until 12 months follow-up

  6. Change in Disability Rating Index (DRI)

    Investigate the change in the disability rating index at each FU visit and compare endpoint between the treatment arms. The change in DRI is defined as the difference between DRI at the respective FU and at the 1-week FU.

    Measured: Implantation until 12 months follow-up

  7. EQ-5D-5L

    Investigate all items assessed in the EQ-5D-5L questionnaire. The changes from Screening will be compared between treatment arms for all FU visits.

    Measured: Implantation until 12 months follow-up

  8. Weight bearing

    Investigate the proportion of subjects with full weight bearing at each FU visit and compare this endpoint between the treatment arms.

    Measured: Implantation until 12 months follow-up

  9. Change in Silver Serum Levels

    Investigate the change in silver serum levels at each scheduled FU visit and compare endpoint between the treatment arms. The change in silver serum level is defined as the difference between the respective silver level at the respective FU and the silver level at Screening/Enrollment Visit.

    Measured: Implantation until 12 months follow-up

  10. Proportion of subjects with Treatment emergent adverse events (TEAE)

    Investigate the proportion of subjects with TEAEs during the 12-month FU and compare the rate between treatment arms.

    Measured: Implantation until 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start9 Dec 2021
  3. Primary completion4 Aug 2025
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05260463
Sponsor's protocol ID
aap001
Status last verified
Sep 2024
First submitted
11 Jan 2022
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36456987

Questions about this trial

What is this clinical trial studying?

A study testing Implantation in people with Fractures, Open and Fractures, Closed, run by aap Implantate AG at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anticipated Adverse Device Effect (AADE) (time frame: Implantation until 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260463, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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