Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
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|ClinicalTrials.gov Identifier: NCT00480727|
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : February 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unstable Cervical Injury||Procedure: Halo pin re-tensioning Procedure: Placebo Re-tensioning||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Determining Optimal Halo Pin Management Practises to Decrease Pin Complications|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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
- Pin Complications [ Time Frame: Treatment duration (approx 12 weeks) ]Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection
- 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
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
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Karly N Wheeler, Bach Prosthetics & Orthotics||The Alfred Hospital, Bayside Health|