Multi-centre PMCF study of INFINITY® Total Ankle System

• Research type

  Research Study

• Full title

  Multi-Centre Observational PMCF-Study of the INFINITY® Total Ankle

• IRAS ID

  190851

• Contact name

  David Townshend

• Contact email

  david.townshend@nhct.nhs.uk

• Sponsor organisation

  Stryker

• Duration of Study in the UK

  13 years, 3 months, 0 days

• Research summary

  UK Post-Market, Prospective, multi-centre, longitudinal,observational
  Clinical Follow-Up Of the INFINITY® Total Ankle System
  
  Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY® Total Ankle System

  500 subjects across 10 sites.

  Subject enrollment will consist of a pre-operative, operative, 6 months, 1 yr., 2 yr., 5yr., 7 yr., 10 yr., and any unscheduled visit as needed.

  Primary Outcome Measure:

  Evaluate the long-term survivorship of the INFINITY® implant over 10 years

  Secondary outcome measures:

  Identify and assess the implant for component loosening and/or subsidence, any osteolysis and/or cyst formation through radiographic evaluation early and throughout the lifetime of the implant.

  Compare improvements in self-reported pain and social interaction for quality of life measures from pre-op through 10 years post operatively; assessed by EuroQol (EQ5D5L).

  Compare pain and functional improvement in the Ankle Osteoarthritis Score (AOS), which is a visual analogue scale specifically designed as a modification of the Foot Function Index.

  Compare the improvement in self-reported pain-free function scores from pre-op through 10 years post-operatively, assessed by the Manchester Oxford Foot Questionnaire (MOXFQ) walking/standing scores.

  Identify and report the safety of the implant in terms of complications and adverse events.

  Inclusion criteria:

  Be 21 years of age at the time of surgery;

  Diagnosed with unilateral and/or bilateral ankle joint disease;

  Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;

  Willing and able to consent to participate (written,informed consent / witnessed verbal consent)

  Willing and able to attend the requested follow-up visits;

  Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System

  Exclusion criteria:

  Subjects currently enrolled in another interventional foot and ankle clinical study;

  Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;

  Subjects requiring revision total ankle replacement of the ankle being considered for study

• REC name

  HSC REC B

• REC reference

  15/NI/0236

• Date of REC Opinion

  26 Nov 2015

• REC opinion

  Further Information Favourable Opinion