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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
44
Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
The Alfred Hospital
Melbourne, Victoria, Australia
Pin Complications
Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection
Time frame: Treatment duration (approx 12 weeks)
Anxiety Text
Time frame: Fortnightly
Pain
Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided
Time frame: Fortnightly
Pin Tension Measurements
Pin tensioned measured fortnightly using torque reading device
Time frame: Fornightly
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