Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480727
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2007-05-29
Brief Title:
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A10704 | None | None | None |