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Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480727
First Posted: May 31, 2007
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayside Health
  Purpose
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

Condition Intervention
Unstable Cervical Injury Procedure: Halo pin re-tensioning Procedure: Placebo Re-tensioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Anxiety Text [ Time Frame: Fortnightly ]
  • Pain [ Time Frame: Fortnightly ]
    Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided

  • Pin Tension Measurements [ Time Frame: Fornightly ]
    Pin tensioned measured fortnightly using torque reading device


Enrollment: 44
Study Start Date: April 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480727


Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Karly N Wheeler, Bach Prosthetics & Orthotics The Alfred Hospital, Bayside Health
  More Information

Publications:
Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00480727     History of Changes
Other Study ID Numbers: 135/07
A10704
First Submitted: May 29, 2007
First Posted: May 31, 2007
Last Update Posted: February 12, 2013
Last Verified: May 2010

Keywords provided by Bayside Health:
Halo Thoracic Orthosis
Re-tension
Pin loosening