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

  Summary of Research
  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.

  Summary of Results
  Thank you to everyone who took part in this study. Your time and attendance at follow-up visits helped improve understanding of ankle replacement surgery and future patient care.

  Study title
  Long-term follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

  Who carried out the research?
  This study was carried out by 7 orthopaedic surgeons at 6 hospitals in 5 countries (United Kingdom, Belgium, France, Canada and Spain).

  The study was sponsored and funded by Smith & Nephew Orthopaedics AG (previous sponsor/funder: Integra LifeSciences), the manufacturer of the Integra® Cadence™ Total Ankle System. The sponsor was involved in study organisation and reporting. The surgeons involved were responsible for patient care.

  Public involvement
  There was no patient or public involvement in the design of this study, as the study was designed to follow standard of care and collect real-life data.

  Why was this research needed?
  People with severe ankle arthritis often experience long-term pain, stiffness and difficulty walking. One treatment option is total ankle replacement, where the damaged ankle joint is replaced with an artificial joint.

  The Integra® Cadence™ Total Ankle System is designed to reduce pain, improve movement and support everyday activities. The study aimed to monitor the long-term safety and effectiveness of this ankle replacement system, as described to participants when they agreed to take part. No individual benefit was guaranteed.

  What were the main questions studied?
  The study looked at how long the ankle replacement remained in place, whether pain, movement and quality of life improved, and what medical problems or complications occurred after surgery.

  Who took part in the study?
  61 adults who had ankle replacement surgery using the Integra® Cadence™ Total Ankle System took part.
  What treatment did participants receive?
  All participants had ankle replacement surgery using the Integra® Cadence™ Total Ankle System.

  What happened during the study?
  After surgery, participants attended clinic visits where doctors examined their ankle, asked about pain and satisfaction, collected questionnaires about daily activities and quality of life, took X-rays to check the implant, and recorded any medical problems or side effects.

  How long did the study last?
  Participants were originally planned to be followed for up to 10 years. However, the study ended earlier than planned for business reasons. This decision was not related to patient safety or problems with the ankle device. As a result, results beyond 2 years after surgery could not be collected.

  What were the results of the study?
  At 2 years after surgery, all ankle replacements were still in place, meaning none needed removal or replacement during this time. One participant required further surgery just over 27 months after their original operation.

  Compared with before surgery, pain was much lower, movement and daily activities improved, and physical health and quality of life improved. Most participants reported being very satisfied with their ankle replacement. One participant reported being very dissatisfied at 2 years.

  What medical problems occurred?
  36 medical events were reported in 27 participants. Some were serious, including one death from pancreatic cancer, which was not related to the ankle device or surgery. A small number of events were related to the device or the surgery. No device defects were reported, and no implant needed removal because of device-related problems.

  How has this study helped patients and researchers?
  The study provides useful information about the short-term safety and performance of this ankle replacement system, helping surgeons and patients make informed decisions and supporting future research and clinical learning.

  Further research
  No further follow-up or additional research is planned as part of this study, as it ended earlier than originally intended due to business decisions (not because of safety concerns).

  Where can I learn more?
  More information is available on ClinicalTrials.gov under reference number NCT03247023.

• 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