Active, not recruitingNo phase
Total Ankle Replacement Versus Arthrodesis Trial
Key facts
- Who runs it
- University College, London
- Where
- United Kingdom17 sites in 1 countryChoose a country to see its sites
- Trial code
- NCT02128555
- ISRCTN60672307
- U1111-1157-4155
- Status
- Active, not recruiting
- People taking part
- 303 people enrolled
- Started
- Jan 2015
- Expected to end
- 28 Feb 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Total Ankle Replacement
- Arthrodesis
- Record updated
- 15 March 2021
Who can take part
- Age
- 50 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Diagnosis of end-stage ankle osteoarthritis
- Aged 50-85 years inclusive
- The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
- The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
- The patient is willing and able to provide written informed consent
Who cannot take part
- Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
- History of local bone or joint infection
- More than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
- • Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
- Any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
- Participant in another clinical trial that would materially impact on their participation in this study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments
The 2 groups in the trial
- ArthrodesisExisting treatment, for comparison
Ankle arthrodesis (fusion)
- Total Ankle ReplacementTreatment being tested
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomised, Multi-centre, Non-blinded, Prospective, Parallel Group Trial of Total Ankle Replacement (TAR) Versus Ankle Arthrodesis in Patients With End Stage Ankle Osteoarthritis, Comparing Clinical Outcomes and Cost-effectiveness.
- Record updated
- 15 March 2021