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Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
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.
Age
60 - No limit years
Sex
ALL
Healthy Volunteers
No
Oslo University Hospital
Oslo, Norway
Start Date
June 1, 2016
Primary Completion Date
June 1, 2021
Completion Date
January 1, 2026
Last Updated
July 13, 2023
120
ACTUAL participants
Compression screws and neutralization plate
DEVICE
Acumed Fibular Rod System
DEVICE
Lead Sponsor
Oslo University Hospital
Collaborators
NCT06085586
NCT06709365
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06518265