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Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00480727
First received: May 29, 2007
Last updated: February 10, 2013
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Pin Complications [ Time Frame: Treatment duration (approx 12 weeks) ] [ Designated as safety issue: Yes ]
    Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection


Secondary Outcome Measures:
  • Anxiety Text [ Time Frame: Fortnightly ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Fortnightly ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 29, 2007
Last Updated: February 10, 2013
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on May 19, 2013