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

May 29, 2007
February 10, 2013
April 2007
July 2009   (final data collection date for primary outcome measure)
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
  • Pin complications including painful loosening and infection [ Time Frame: Treatement duration (approx 12 weeks) ]
  • Number of halo pins requiring re-site [ Time Frame: Treatment duration (approx 12 weeks) ]
  • Pain measured on a numerical rating scale 1-10 [ Time Frame: Fortnightly ]
  • Pin tension measurements [ Time Frame: Fortnightly ]
Complete list of historical versions of study NCT00480727 on ClinicalTrials.gov Archive Site
  • 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
Anxiety Text [ Time Frame: Fortnightly ]
Not Provided
Not Provided
 
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Unstable Cervical Injury
  • Procedure: Halo pin re-tensioning
    Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
  • 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.
  • Placebo Comparator: Control
    No fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened.
    Intervention: Procedure: Placebo Re-tensioning
  • Experimental: Treatment (Re-tensioning) Group
    Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch.
    Intervention: Procedure: Halo pin re-tensioning

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00480727
135/07, A10704
No
Bayside Health
Bayside Health
Not Provided
Principal Investigator: Karly N Wheeler, Bach Prosthetics & Orthotics The Alfred Hospital, Bayside Health
Bayside Health
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP