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Minimally Invasive Intramedullary Fixation Versus Plate Fixation of Distal Fibular Fractures in Elderly Patients: Study Protocol for a Prospective Multicenter Cohort Study

Minimally Invasive Intramedullary Fixation Versus Plate Fixation of Distal Fibular Fractures in Elderly Patients: Study Protocol for a Prospective Multicenter Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20210
Enrollment
80
Registered
2019-07-23
Start date
2019-07-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

fibula, fracture, intramedullary fixation, nail, plate fixation, elderly, prospective cohort

Interventions

1) Minimally invasive intramedullary fixation using a fibular nail 2) Conventional plate fixation

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 70 years or older 2) Fracture classified as Lauge-Hansen supination external rotation type 4 including fracture associated with luxation of the ankle joint 3) Articular discongruity of >2 mm on X-ray

Exclusion criteria

Exclusion criteria: 1) Pathological fractures 2) Severely comminuted fractures (>75%) 3) Presentation delayed by >14 days 4) Polytrauma patients (>2 AIS or >15 ISS with two or more anatomic regions involved) 5) Inoperable patients

Design outcomes

Primary

MeasureTime frame
The total number of postoperative complications, including wound infection, wound healing disorders, implant related complications, deep venous thrombosis, pulmonary embolism, and mortality.

Secondary

MeasureTime frame
Functional scores (including the Olerud-Molander Ankle Score, Parker Mobility Score and Visual Analogue Scale for pain), duration of hospital stay, and number of postoperative hospital visits.

Contacts

Public ContactDavid Tas

Department of Surgery, University Medical Center Utrecht, Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.

davidbtas@gmail.com+31 (0)6 16896301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)