Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

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

Detailed Description
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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.

Official Title
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Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Conditions
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Unstable Cervical Injury

Intervention / Treatment
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* Procedure: Halo pin re-tensioning
* Procedure: Placebo Re-tensioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital Exclusion Criteria: Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>No fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened. | Procedure: Placebo Re-tensioning<br>* Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.<br>|
| Experimental: Treatment (Re-tensioning) Group<br>Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch. | Procedure: Halo pin re-tensioning<br>* Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pin Complications | Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection | Treatment duration (approx 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Text |  | Fortnightly | 
| Pain | Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided | Fortnightly | 
| Pin Tension Measurements | Pin tensioned measured fortnightly using torque reading device | Fornightly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Halo Thoracic Orthosis, Re-tension, Pin loosening