None listed
Conditions
Brief summary
The aim of this study is to investigate clinical and patient reported outcomes following total ankle arthroplasty (TAA). The study will comprise a consecutive observational cohort with retrospective and prospective study design. Recruitment will include patients who have presented with ankle pathology to the principal investigators, Dr Andrew Wines and Dr Michael Symes, and elected to undergo TAA procedure. Patients will be presented with a Participant Information Sheet to inform them of the nature of the study and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-in approach. The data collection process will involve retrospective chart review and collection of patient demographic, treatment and clinical data as well as patient reported outcome scores collected routinely as part of the standard clinical pathway at the baseline presentation. Consenting patients will also be requested to complete a set of questionnaires (FAOS, satisfaction) to enable evaluation of patient reported outcomes as part of the post- treatment follow up. Aggregated pooled results will be deidentified, analysed and reported in the form of a manuscript for publication in a peer-review journal.
Interventions
Population : Patients presenting with end-stage pathologies of the ankle and referred to specialist orthopaedic review
Exposure: Primary total ankle arthroplasty (TAA) with the Zimmer Biomet Trabecular Metal™ Total Ankle
Retrospective data will be extracted from medical records of patients who underwent a primary total ankle arthroplasty procedure between September 2016 and February 2020 under the provision of the participating orthopaedic surgeons. Data collected will include clinical, demogr
Population : Patients presenting with end-stage pathologies of the ankle and referred to specialist orthopaedic review Exposure: Primary total ankle arthroplasty (TAA) with the Zimmer Biomet Trabecular Metal™ Total Ankle Retrospective data will be extracted from medical records of patients who underwent a primary total ankle arthroplasty procedure between September 2016 and February 2020 under the provision of the participating orthopaedic surgeons. Data collected will include clinical, demographic, pathological and treatment data collected for TAA patients as part of the standard clinical pathway. Baseline patient reported outcome measures (PROMs) and occurrence of complications will also be retrospectively retrieved from the surgeons' practice management systems. For the purpose of the study, participants will be asked to report their satisfaction with the TAA surgery and latest health status via the administration of a PROMs questionnaire pack at a single follow up timepoint. It is estimated the questionnaires will take approximately 20 minutes to complete. Follow up data will be reported at up to 4 years post-operatively, depending on the participant surgery dates.
Sponsors
Dr Andrew Wines
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (>18y) diagnosed with end-stage osteoarthritis of the ankle by the principal investigators/participating consultant orthopaedic surgeons Electing to undergo primary surgical TAA with the Zimmer Biomet Trabecular Metal™ Total Ankle by principal investigators/participating consultant orthopaedic surgeons Baseline clinical history and questionnaires are available for the patient in the practice management system
Exclusion criteria
Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder). Revocation of consent for research use of personal data. Revision TAA Primary cases with a non-Zimmer implant OR performed in the public hospital
Outcome results
None listed