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ID
Source
Brief title
Health condition
fibula, fracture, intramedullary fixation, nail, plate fixation, elderly, prospective cohort
Sponsors and support
Intervention
Outcome measures
Primary outcome
The total number of postoperative complications, including wound infection, wound healing disorders, implant related complications, deep venous thrombosis, pulmonary embolism, and mortality.
Secondary outcome
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.
Background summary
Background:
Intramedullary fixation using a fibular nail is a minimally invasive alternative to conventional plate fixation for operative treatment of distal fibular fractures. This surgical technique has been described to decrease postoperative complications associated with plate fixation and has been suggested to be superior in elderly patients and in patients with compromised soft tissue or severe comorbidities.
Objective:
The aim of this study is to compare the postoperative complications and functional outcomes of intramedullary nail fixation and conventional plate fixation for Lauge-Hansen supination external rotation type 4 or luxation fractures in patients aged 70 years or older.
Design:
This is a prospective multicenter observational cohort study involving two level 2 trauma centers (St Antonius Hospital, Nieuwegein and the Diakonessenhuis, Utrecht). Patients aged 70 years or older with a Lauge-Hansen supination external rotation type 4 or luxation fracture requiring surgical fixation are eligible for inclusion. Patients are treated with either intramedullary nail fixation in the St Antonius Hospital or plate fixation in the Diakonessenhuis according to standard protocol.
Study endpoints:
The primary outcome measure is 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 are 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.
Study objective
Compared to plate fixation, intramedullary fixation allows a minimally invasive technique using smaller incisions and a low-profile implant, causing less postoperative complications by avoiding extensive soft tissue injury, eventually resulting in a decreased number of postoperative complications.
Study design
Intake, 2 weeks, 6 weeks, 3 months and 12 months postoperatively
Intervention
1) Minimally invasive intramedullary fixation using a fibular nail
2) Conventional plate fixation
David Tas
+31 (0)6 16896301
davidbtas@gmail.com
David Tas
+31 (0)6 16896301
davidbtas@gmail.com
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7892 |
| Other | Medical research Ethics Committees United (MEC-U) : W19.025 |