Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

February 10, 2013 updated by: Bayside Health
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
Experimental: Treatment (Re-tensioning) Group
Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch.
Procedure: Halo pin re-tensioning
Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pin Complications
Time Frame: Treatment duration (approx 12 weeks)
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
Time Frame: Fortnightly
Fortnightly
Pain
Time Frame: Fortnightly
Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided
Fortnightly
Pin Tension Measurements
Time Frame: Fornightly
Pin tensioned measured fortnightly using torque reading device
Fornightly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Investigators

  • Principal Investigator: Karly N Wheeler, Bach Prosthetics & Orthotics, The Alfred Hospital, Bayside Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 31, 2007

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 10, 2013

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 135/07
  • A10704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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