RecruitingACTRN12617001588381

Transarticular tibio-talo-calcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: a multi-centre, prospective, randomised controlled trial.


Sponsor

Princess Alexandra Hospital

Enrollment

110 participants

Start Date

Mar 30, 2018

Study Type

Interventional

Conditions

Summary

This is a surgical study comparing traditional methods of ORIF (plates and screws) versus a new technique of hindfoot nailing in elderly patients with ankle fractures. The proposed benefit of hindfoot nailing is that participants can put weight through their ankle earlier, however it locks the ankle and does not allow it to move. At this point in time it is unknown which technique has better outcomes.


Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria4

  • Isolated, displaced, closed ankle fracture
  • Age greater than or equal to 50
  • Charlson morbidity index greater than or equal to four
  • Unstable fracture or fracture dislocation determined by treating team to require operative intervention

Exclusion Criteria6

  • Peri-prosthetic fractures
  • Open fractures
  • Patient medically not fit for surgery
  • Requirement of removal of previous metalwork
  • Cognitive impairment limiting ability to give informed consent
  • Significant language barrier limiting ability to give informed consent

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Interventions

Intervention name: Transarticular Tibio-talo-calcaneal (TTC) nailing TTC nailing will be performed using the Styker T2 Ankle Arthrodesis Nail. The patient’s foot is positioned in neutral dorso-plan

Intervention name: Transarticular Tibio-talo-calcaneal (TTC) nailing TTC nailing will be performed using the Styker T2 Ankle Arthrodesis Nail. The patient’s foot is positioned in neutral dorso-plantar flexion, five to ten degrees of external rotation and 5 degrees of hindfoot valgus. Closed reduction of the fracture is performed under image intensifier (ii) guidance. The longitudinal axis of the calcaneus and tibia are marked on the patient using a Kirschner wire (K-wire) and a marking pen. A 2-3 cm longitudinal incision is made at the intersection of the marked lines, followed by soft tissue dissection to gain access to the plantar aspect of the calcaneus. A K-wire is then inserted through the incision, and after confirmation of positioning with ii is progressed through the calcaneus, across the subtalar and talocrural joints and into the tibial medullary canal. A rigid reamer is used over the wire and reamed until it reaches the medullary canal of the tibia. A ball-tipped guide is then passed into the tibia with sequential reaming over the wire to 1-1.5mm greater than the nail diameter previously selected. The nail is then locked with two screws proximally through the tibial shaft, and two distally in the calcaneus in orthogonal planes. Skin will be closed with 3.0 nylon interrupted sutures. Patients will be placed in a cam walker and allowed to full weight bear day one post-operatively. All operations are to be performed by consultant orthopaedic surgeons or their trainees under direct supervision. Patients are positioned supine on a radiolucent table with a sandbag under the ipsilateral hip. All patients will receive intravenous antibiotics. A tourniquet will be used for all operations.. Operations approximate 60-120min in duration.


Locations(3)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Cairns Base Hospital - Cairns

QLD, Australia

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ACTRN12617001588381


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