The TASI Study

The TASI Study will test the potential overall benefit of the TightRope versus syndesmotic screw fixation for ankle injuries.

The TASI Study

Background

  • The TightRope (Arthrex Inc, Naples, Florida) is a relatively new surgical implant based on the suture-button design
  • It has been suggested that while the implant device is more expensive than screws, health economic benefit exists because of earlier weight bearing and potential to earlier to return to employment, fewer secondary procedures, and fewer post operative complications
  • The potential overall benefit of the TightRope versus syndesmotic screw fixation for ankle injuries, both with respect to patient outcomes and the overall health cost, analysis has not been formally studied in a New Zealand setting

Facts

  • A syndesmosis injury can lead to instability in the ankle joint, loss of function, and rapid joint degeneration
  • Tibiofibular fixation using a screw across the syndesmosis has historically been the most popular stabilising method for displaced injuries of the ankle syndesmosis
  • A recent randomised multi centre study in Canada and Holland has shown promising results, with endo-button fixation reporting greater functional outcome scores

Aims

Primary: to compare the effectiveness of TightRope to standard screw stabilisation of the syndesmosis in adults with AO type C ankle injuries requiring fixation of the syndesmosis, with regards to functional outcome 6 months post treatment.

Secondary:
To compare the accuracy and maintenance of syndesmotic reduction, and its correlation with clinical outcomes and complications.
Compare the direct cost of each procedure using a hospital perspective.

Methods

  • A 160 patient, multi-centre, randomised, controlled, clinical trial of eighteen months duration
  • Eligible patients will be randomised 1:1 to receive either the Tightrope endo-button device or standard syndesmotic screw fixation
  • TASI will be conducted in hospitals in Australia and New Zealand

Supported by:
The New Zealand Orthopaedic Association (NZOA).
Surgical Research Trust, Wellington, New Zealand.

Coordinating centre: Capital & Coast District health Board.

Chief Investigator: Mr Nigel Willis, Orthopaedic Consultant, Wellington Regional Hospital.

Contact: Nik Florance, Specialty Clinical Nurse/Acute Coordinator – Orthopaedics, Capital & Coast District Health Board.

Software: Spinnaker, Spiral Software.

Download the TASI Fact Sheet (pdf)

Twitter

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#TASItrial

Read what people are saying about the TASI Trial on Twitter.
#TASItrial

Study Database

Sign in to the study (username + password needed)

Study Database

The TASI Trial is open and enrolling patients. If you have a username and password you can sign in from here.
Study Database

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry

ANZCTR

View this trial on the Australian and New Zealand Clinical Trial Registry. 
ACTRN12614000010695