Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.

Oslo University Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Ankle Fractures

Interventions

Compression screws and neutralization plateDEVICE

Open reduction and internal fixation with screws and plate

Acumed Fibular Rod SystemDEVICE

intramedullary nailing of fibula

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

American Orthopaedic Foot and Ankle Society (AOFAS) score

Functional outcome as assessed by AOFAS score (0-100)

Time frame: 5 years

Secondary Outcomes

Manchester-Oxford Foot questionnaire (MOxFQ)

Patient reported outcome as assessed by MOxFQ (0-100)

Time frame: 5 years

Olerud and Molander Score (OMS)

Patient reported outcome as assessed by OMS (0-100)

Time frame: 5 years

EuroQol-5d (Eq-5d)

Patient reported quality of life as assessed by Eq-5d index score

Time frame: 5 years

Visual analogue scale (VAS)

VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best

Time frame: 5 years

Fracture reduction as assessed by CT scans

Number of patients with good, fair or poor fracture reduction

Time frame: 3 months

Malunion as assessed by CT scans

Number of patients with malunion

Time frame: 5 years

Nonunion as assessed by CT scans

Number of patients with nonunion

Time frame: 5 years

Osteoarthritis as assessed by CT scans

Data from ClinicalTrials.gov

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