T-CTAS-002

• Research type

  Research Study

• Full title

  Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

• IRAS ID

  233244

• Contact name

  Marilyne Blanc

• Contact email

  marilyne.blanc@integralife.com

• Sponsor organisation

  Integra LifeSciences Corporation

• Clinicaltrials.gov Identifier

  NCT03247023

• Duration of Study in the UK

  12 years, 0 months, 1 days

• Research summary

  This study will evaluate the long term performance (at 2, 5, 10 years) and safety data for the CTAS when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). The study will collect data on the survivorship of the Cadence Total Ankle Prosthesis and the results will enable the medical community to assess the postoperative quality of life of future patients.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  18/NW/0142

• Date of REC Opinion

  22 Mar 2018

• REC opinion

  Further Information Favourable Opinion