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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain,
pin loosening and pin replacement.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00480727
Trial related presentations / 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 (Phila Pa 1976). 1997 Nov 1;22(21):2514-6. doi: 10.1097/00007632-199711010-00010.
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