Unstable Cervical Injury Clinical Trial
Official title:
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.
Halo Thoracic Orthoses (Halos) are used to immobilise unstable cervical fractures. The halo
grips the skull via 4 pins. Pin loosening is a major complication of halo wear. Pin
loosening is painful and can result in loss of control of the fractures. Treatment is
required urgently and involves re-siting the pin.
Comparisons: This study will compare two pin management practises with the aim to determine
which is optimal to reduce the incidence of complications including pin loosening. Patients
will be randomly allocated into 2 groups. The control group will receive treatment in
accordance with current practise at The Alfred, the pins will not be re-tensioned throughout
the treatment period. The alternative treatment group will have their pins re-tensioned
fortnightly.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention