Unstable Cervical InjuryNCT00480727
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
A study testing Halo pin re-tensioning in people with Unstable Cervical Injury, run by Bayside Health at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Cervical Injury
- What is being tested?
- Halo pin re-tensioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital
Who cannot join
- Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.
Read the 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.
- Conditions
- Unstable Cervical Injury
- Being tested
- Halo pin re-tensioning, Placebo Re-tensioning
- Keywords
- Halo Thoracic Orthosis, Re-tension, Pin loosening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halo pin re-tensioningProcedure or surgery
Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch
Placebo Re-tensioningProcedure or surgery
Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened. Receives: Procedure: Placebo Re-tensioning |
| Treatment (Re-tensioning) Group | Experimental | Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch. Receives: Procedure: Halo pin re-tensioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pin Complications
Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection
Measured: Treatment duration (approx 12 weeks)
Secondary outcomes (3)
Anxiety Text
Measured: Fortnightly
Pain
Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided
Measured: Fortnightly
Pin Tension Measurements
Pin tensioned measured fortnightly using torque reading device
Measured: Fornightly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unstable Cervical InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karly N Wheeler, Bach Prosthetics & Orthotics, Principal investigator, The Alfred Hospital, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480727
- Sponsor's protocol ID
- 135/07
- Other IDs
- A10704
- Status last verified
- May 2010
- First submitted
- 29 May 2007
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuester WM, Stamper RE, Ordway NR. Analysis of pin force distributions of halo orthoses. Biomed Sci Instrum. 2002;38:221-6.
PubMed 12085606Garfin 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.
PubMed 3949826Vertullo 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.
PubMed 9383858
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
- ClinicalTrials.gov ID
- NCT00480727
- Acronym / sponsor ID
- 135/07
- Conditions
- Unstable Cervical Injury
- Keywords
- Halo Thoracic Orthosis, Re-tension, Pin loosening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Placebo Re-tensioningNo fortnightly re-tensioning. Placebo treatment utilises the re-tensioning procedure, pt experiences clicking sensation, however, the pin is not tightened. |
| Treatment (Re-tensioning) Group | Experimental | Procedure: Halo pin re-tensioningPins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital
Key exclusion criteria (1 listed)
- Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Halo pin re-tensioningRe-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch | Procedure or surgery | Treatment (Re-tensioning) Group |
| Placebo Re-tensioningPts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin. | Procedure or surgery | Control |
Primary outcome
Pin Complications
Time frame: Treatment duration (approx 12 weeks)
Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection
3 secondary outcomes
Anxiety Text
Time frame: Fortnightly
Pain
Time frame: Fortnightly
Pin Tension Measurements
Time frame: Fornightly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Background: PubMed 12085606Kuester WM, Stamper RE, Ordway NR. Analysis of pin force distributions of halo orthoses. Biomed Sci Instrum. 2002;38:221-6.
- Background: PubMed 3949826Garfin 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.
- Background: PubMed 9383858Vertullo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karly N Wheeler, Bach Prosthetics & Orthotics principal investigator
The Alfred Hospital, Bayside Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halo pin re-tensioning in people with Unstable Cervical Injury, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pin Complications (time frame: Treatment duration (approx 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.