Minimally Invasive Intramedullary Fixation Versus Plate Fixation of Distal Fibular Fractures in Elderly Patients: Study Protocol for a Prospective Multicenter Cohort Study
Recruiting
- Conditions
- fibula, fracture, intramedullary fixation, nail, plate fixation, elderly, prospective cohort
- Registration Number
- NL-OMON20210
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The total number of postoperative complications, including wound infection, wound healing disorders, implant related complications, deep venous thrombosis, pulmonary embolism, and mortality.
- Secondary Outcome Measures
Name Time Method 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.