Last reviewed · How we verify
NCT05260463
LOQTEQ® Antibacterial Pre-Market Study
NA trial testing Implantation in Fractures, Open in 203 participants. Completed in 4 August 2025.
4 August 2025
Quick facts
| Lead sponsor | aap Implantate AG |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 203 |
| Start date | 9 December 2021 |
| Primary completion | 4 August 2025 |
| Estimated completion | 4 August 2025 |
| Sites | 13 locations across Germany |
Drugs / interventions tested
- Implantation — full drug profile →
Conditions studied
- Fractures, Open — all drugs for Fractures, Open →
- Fractures, Closed — all drugs for Fractures, Closed →
- Surgical Site Infection — all drugs for Surgical Site Infection →
- Fracture of Fibula — all drugs for Fracture of Fibula →
Sponsor
aap Implantate AG
Who can join
18 and older, any sex, with Fractures, Open or Fractures, Closed. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Schoder S, Lafuente M, Alt V. · · 2022 · cited 4× · PMID 36456987 · DOI 10.1186/s13063-022-06919-0
Verify or expand the search:
- PubMed search for NCT05260463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Implantation
Trials testing the same drug.
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- NCT04449211 — The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant · EARLY_PHASE1 · recruiting
- NCT05279157 — Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD) · Phase 2 · completed
- NCT03887494 — Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) · NA · unknown
Other recruiting trials for Fractures, Open
Currently open trials in the same condition.
- NCT04299022 — Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05260463 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by aap Implantate AG
- Last refreshed: 18 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05260463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing