NCT00480727

Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Bayside Health · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

Detailed description

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.

Conditions

• Unstable Cervical Injury

Interventions

Type	Name	Description
PROCEDURE	Halo pin re-tensioning	Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
PROCEDURE	Placebo Re-tensioning	Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-05-31
• Last updated: 2013-02-12

Locations

1 site across 1 country: Australia