Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

Bayside Health

Status: Completed

Conditions: Unstable Cervical Injury

Treatments: Procedure: Halo pin re-tensioning; Procedure: Placebo Re-tensioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00480727

135/07

A10704

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

No fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened.

Treatment:

Procedure: Placebo Re-tensioning

Treatment (Re-tensioning) Group

Experimental group

Description:

Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch.

Treatment:

Procedure: Halo pin re-tensioning