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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025496
Enrollment
40
Registered
2021-07-05
Start date
2015-06-01
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

S82.6

Interventions

Group 1: If osteosynthesis of a distal fibula fracture is indicated, the osteosynthesis is performed after a randomisation process by means of a Semitubular plate and a screw using the AO (Arbeitesgem

Sponsors

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

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Primary target parameters: Radiological-morphological: Position of the fracture fragments Clinical-functional: Weight-bearing and range of motion according to the neutral zero method Consolidation of the tissue

Secondary

MeasureTime frame
Secondary target parameters: Radiological-morphological: Development of the fracture Axial position (in the upper ankle joint) Clinical data: Medical history (risk factors, secondary diagnoses, family history). Patient satisfaction (SF-36 II) Complications Pain (analgesic requirement) Range of motion (n. neutral zero)

Countries

Germany

Contacts

Public ContactMichael Zyskowski

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

Michael.Zyskowski@mri.tum.de089/41402126

Outcome results

None listed

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