Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00480727

Enrollment

Registered

2007-05-31

Start date

2007-04-30

Completion date

2009-07-31

Last updated

2013-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unstable Cervical Injury

Keywords

Halo Thoracic Orthosis, Re-tension, Pin loosening

Brief summary

The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

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.

Interventions

PROCEDUREHalo pin re-tensioning

Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch

PROCEDUREPlacebo 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pin Complications	Treatment duration (approx 12 weeks)	Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection

Secondary

Measure	Time frame	Description
Anxiety Text	Fortnightly	—
Pain	Fortnightly	Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided
Pin Tension Measurements	Fornightly	Pin tensioned measured fortnightly using torque reading device

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026