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Implantation of tibal nailing systems in infected non-unions

Implantation of tibal nailing systems in infected non-unions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032533
Enrollment
47
Registered
2023-09-05
Start date
2022-03-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M86.6

Interventions

Group 1: A retrospective analysis of patients with infected non-unions of the tibia who underwent implantation of a gentamycin-coated nail (ETN=Expert Tibial Nail PROtect
Synthes) between 12/2011 and 12/2019. Preoperative, perioperative, and postoperative follow-up were evaluated. The follow-up was analyzed up to 12/2021. Group 2: A retrospective analysis of patients w
Stryker) between 12/2011 and 12/2019. Preoperative, perioperative, and postoperative follow-up were evaluated. The follow-up was analyzed up to 12/2021.

Sponsors

BG Klinikum Duisburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Chronic Osteomyelitis or a tibial non union with highly suspicious sings of infection - tibial nail with either a gentamycin-coated or an uncoated tibial nail

Exclusion criteria

Exclusion criteria: aseptic non- union of the tibia or different surgical procedure

Design outcomes

Primary

MeasureTime frame
- successful control of infection

Secondary

MeasureTime frame
- osseous consolidation of the non-union - functional outcome or mobilization under full weight bearing - the reduction of systemic antibiotics -all complications including infection re-exacerbation, re-operations with the number of revisions and treatment failures, -number of patients who have been treated unsuccessfully with an external fixator before intramedullary nailing

Countries

Germany

Contacts

Public ContactVictoria Heck

BG Klinikum Duisburg

victoria.heck@bg-klinikum-duisburg.de+49 203 7688 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026