Introduction Ankle fractures are common in the elderly population. Surgical fixation is technically challenging and often results in complications due to high rates of osteoporosis and vascular disease. Open reduction and internal fixation (ORIF) often requires prolonged periods of non-weight bearing increasing the risks of complications. Tibiotalocalcaneal (TTC) nailing has been suggested as an alternative to ORIF which allows immediate weight bearing, and is suggested to result in fewer complications. This study aims to compare the two surgical techniques in the elderly population with ankle fractures.
Methods and analysis The study will be a multicentre, prospective, randomised controlled trial comparing ORIF to TTC nailing in 110 patients with ankle fractures aged 50 or above with a Charlson Comorbidity Index of greater than or equal to four. Participants and assessors will not be blinded to intervention. The primary outcome measure will be overall complication rate. Secondary outcomes include length of hospital stay, mobility at discharge, discharge destination, the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot score, the Olerud-Molander Ankle Score, mortality rate, rate of secondary surgical interventions and number of blood transfusions required postoperatively. Our null hypothesis is that there is no clinically significant difference in the primary outcome measure between the two treatment groups.
Ethics and dissemination The study has been approved by Metro South Hospital and Health Services Human Research Ethics Committee (EC00167) (reference number HREC/17/QPAH/351).
Discussion Completion of this trial will provide evidence on the effectiveness of TTC nailing versus ORIF in treatment of the elderly ankle fracture. If TTC nailing is found to result in superior outcomes, this trial has the capacity to change current clinical practice.
Trial registration number ACTRN12617001588381;Pre-results andU1111-1203-1704.
- ankle fractures
- fracture fixation
- hindfoot nail
- open reduction internal fixation
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Patient consent for publication Not required.
Contributors CM, MH and KT conceived the study. PT, MH, KT, JV and CM developed the current protocol. All authors read and approved the final manuscript.
Funding This study is in part funded by Stryker Australia Pty Ltd (ACN 002873850).
Competing interests Grant funding has been received by Stryker Australia Pty Ltd (ACN 002873850). Stryker Australia Pty Ltd is the manufacturer of the T2 arthrodesis nail used in the trial for TTC nailing. Funds obtained from Stryker will assist in the hiring of a research assistant who will be responsible for co-ordination of data collection from individual institutions. Selection of this assistant will be the responsibility of the principle investigator and will not have input from the funding body. Data analysis will be performed by a third party not affiliated with the sponsor. None of the authors have financial interests linked to Stryker Australia.
Ethics approval This study was granted ethics approval by the Metro South Human Research Ethics Committee (EC00167) HREC/17/QPAH/351).
Provenance and peer review Not commissioned; externally peer reviewed.
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