Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
NCT ID: NCT00480727
Last Updated: 2013-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-04-30
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
No fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened.
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.
Treatment (Re-tensioning) Group
Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch.
Halo pin re-tensioning
Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Bayside Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Karly N Wheeler, Bach Prosthetics & Orthotics
Role: PRINCIPAL_INVESTIGATOR
The Alfred Hospital, Bayside Health
Locations
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The Alfred Hospital
Melbourne, Victoria, Australia
Countries
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References
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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 (Phila Pa 1976). 1997 Nov 1;22(21):2514-6. doi: 10.1097/00007632-199711010-00010.
Other Identifiers
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A10704
Identifier Type: -
Identifier Source: secondary_id
135/07
Identifier Type: -
Identifier Source: org_study_id
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