Determining Optimal Halo Pin Management Practises to Decrease Pin Complications - Full Text View

Sponsored by:	Bayside Health
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00480727

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Further study details as provided by Bayside Health:

Primary Outcome Measures:

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 ]
Pin complications including painful loosening and infection [ Time Frame: Treatement duration (approx 12 weeks) ]

Secondary Outcome Measures:

Anxiety Text [ Time Frame: Fortnightly ]

Estimated Enrollment:	50
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2008

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

Contacts

Contact: Karly N Wheeler, Bach Prosthetics & Orthotics	061 3 9076 3182 ext 63182	K.Wheeler@alfred.org.au
Contact: Gavin Burchall, Bach Prosthetics & Orthotics	061 3 9076 3182 ext 63182	G.Burchall@alfred.org.au

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:

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

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.

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

Study ID Numbers:	135/07, A10704
Study First Received:	May 29, 2007
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00480727
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 January 13, 2009