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Clinical Trials/DRKS00025496
DRKS00025496
Completed
Phase 4

Functional outcome of distal fibula fractures comparing conventional AO-semitubular plating to minimally invasive intramedullary Photodynamic Bone Stabilization.

TUM, Klinikum rechts der Isar, Klinik und Poliklinik für Unfallchirurgie0 sites45 target enrollmentJuly 5, 2021
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ConditionsS82.6Fracture of lateral malleolus

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
S82.6
Sponsor
TUM, Klinikum rechts der Isar, Klinik und Poliklinik für Unfallchirurgie
Enrollment
45
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2021
End Date
August 6, 2018
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
TUM, Klinikum rechts der Isar, Klinik und Poliklinik für Unfallchirurgie

Eligibility Criteria

Inclusion Criteria

  • •Presence of a distal fibula fracture (according to AO 44 B1\.1, B1\.2, B1\.3\).
  • •\- Fulfilment of the criteria for surgical treatment:
  • •\- Corticalis disruption
  • •\- Shaft displacement \>5mm
  • •\- Grade 0: No or insignificant soft tissue injury, indirect force, simple fracture form
  • •\- Grade I: Superficial skin abrasion or contusion due to fragment pressure from inside, simple to moderate fracture form
  • •\- Age: \> 65 years
  • •\- Charlson score \= 1

Exclusion Criteria

  • •\- Open fractures
  • •\- Lesions of the vessels or nerves
  • •\- Presence of a pathological fracture
  • •\- Polytrauma patients
  • •\- Prisoners, pregnant women and patients with known care needs
  • •\- Inflammatory underlying disease such as: sepsis, meningitis, HIV, hepatitis, etc.
  • •\- Neurological\-psychiatric underlying disease

Outcomes

Primary Outcomes

Not specified

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