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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00480727




Registration number
NCT00480727
Ethics application status
Date submitted
29/05/2007
Date registered
31/05/2007
Date last updated
12/02/2013

Titles & IDs
Public title
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Scientific title
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Secondary ID [1] 0 0
A10704
Secondary ID [2] 0 0
135/07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unstable Cervical Injury 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Halo pin re-tensioning
Treatment: Surgery - Placebo Re-tensioning

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

Experimental: Treatment (Re-tensioning) Group - Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch.


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

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pin Complications
Timepoint [1] 0 0
Treatment duration (approx 12 weeks)
Secondary outcome [1] 0 0
Anxiety Text
Timepoint [1] 0 0
Fortnightly
Secondary outcome [2] 0 0
Pain
Timepoint [2] 0 0
Fortnightly
Secondary outcome [3] 0 0
Pin Tension Measurements
Timepoint [3] 0 0
Fornightly

Eligibility
Key inclusion criteria
* Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karly N Wheeler, Bach Prosthetics & Orthotics
Address 0 0
The Alfred Hospital, Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00480727