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Completed

NCT Number: NCT00480727

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.

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Key information

Conditions

Unstable Cervical Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Halo pin re-tensioning

Procedure

Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch

Placebo Re-tensioning

Procedure

Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.

Primary outcomes

  1. Pin Complications

    Time frame: Treatment duration (approx 12 weeks)

    Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection

Secondary outcomes

  1. Anxiety Text

    Time frame: Fortnightly

  2. Pain

    Time frame: Fortnightly

    Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided

  3. Pin Tension Measurements

    Time frame: Fornightly

    Pin tensioned measured fortnightly using torque reading device

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 31, 2007
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.