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NCT00480727 Clinical Trial

Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Unstable Cervical Injury Clinical Trial

Official title:
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00480727
Other study ID # 135/07
Secondary ID A10704
Status Completed
Phase N/A
First received May 29, 2007
Last updated February 10, 2013
Start date April 2007
Est. completion date July 2009

Study information
Verified date May 2010
Source Bayside Health
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Halo pin re-tensioning
Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
• 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.

Locations
Country Name City State
Australia The Alfred Hospital Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

References & Publications (3)

Garfin SR, Botte MJ, Waters RL, Nickel VL. Complications in the use of the halo fixation device. J Bone Joint Surg Am. 1986 Mar;68(3):320-5. — View Citation

Kuester WM, Stamper RE, Ordway NR. Analysis of pin force distributions of halo orthoses. Biomed Sci Instrum. 2002;38:221-6. — View Citation

Vertullo CJ, Duke PF, Askin GN. Pin-site complications of the halo thoracic brace with routine pin re-tightening. Spine (Phila Pa 1976). 1997 Nov 1;22(21):2514-6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pin Complications Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection Treatment duration (approx 12 weeks) Yes
Secondary Anxiety Text Fortnightly No
Secondary Pain Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided Fortnightly No
Secondary Pin Tension Measurements Pin tensioned measured fortnightly using torque reading device Fornightly No