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| ID | Type | Description | Link |
|---|---|---|---|
| A10704 |
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The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | No 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 | Pins are re-tensioned fortnightly back to initial fitting tension of 8lb/inch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Halo pin re-tensioning | Procedure | Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pin Complications | Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection | Treatment duration (approx 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Text | Fortnightly | |
| Pain | Pain measured on a numerical rating scale 0-10 at each review both before and after treatment is provided | Fortnightly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karly N Wheeler, Bach Prosthetics & Orthotics | The Alfred Hospital, Bayside Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12085606 | Background | Kuester WM, Stamper RE, Ordway NR. Analysis of pin force distributions of halo orthoses. Biomed Sci Instrum. 2002;38:221-6. | |
| 3949826 | Background | 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. |
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| Placebo Re-tensioning | Procedure | Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin. |
|
| Pin Tension Measurements | Pin tensioned measured fortnightly using torque reading device | Fornightly |
| 9383858 | Background | 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. |