Clinical trial NCT03377205: Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
Official title: Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Ostfold Hospital Trust
name: Vestre Viken Hospital Trust
First posted: 2017-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.

Detailed description: Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.

Eligibility criteria: Inclusion Criteria:

* Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
* Operable with both methods of surgery within 3 weeks after injury.
* Men and women ≥ 60 yoa.

Exclusion Criteria:

* Prior injury or pathology with reduced ankle function.
* Other acute foot/ankle/leg injury that will affect ankle function.
* Fracture of the posterior malleolus that need fixation.
* Injury / pathology that may affect rehabilitation.
* Open fracture.
* Inoperable patient.
* Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) score
timeFrame: 5 years
Secondary outcomes:
measure: Manchester-Oxford Foot questionnaire (MOxFQ)
timeFrame: 5 years
measure: Olerud and Molander Score (OMS)
timeFrame: 5 years
measure: EuroQol-5d (Eq-5d)
timeFrame: 5 years
measure: Visual analogue scale (VAS)
timeFrame: 5 years
measure: Fracture reduction as assessed by CT scans
timeFrame: 3 months
measure: Malunion as assessed by CT scans
timeFrame: 5 years
measure: Nonunion as assessed by CT scans
timeFrame: 5 years
measure: Osteoarthritis as assessed by CT scans
timeFrame: 5 years
measure: Infection
timeFrame: 3 months
measure: Delayed wound healing
timeFrame: 3 months
measure: Other complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Elisabeth E Husebye, MD, PhD
role: STUDY_CHAIR
References: