Clinical trial NCT02128555: Total Ankle Replacement Versus Arthrodesis Trial
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: ankle arthritis
osteoarthritis
total ankle replacement
arthrodesis
quality of life
musculoskeletal
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-05-01
Enrollment: 303
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This is a randomised, multi-centre, non-blinded, prospective, parallel-group trial of TAR versus ankle arthrodesis in patients with end-stage ankle osteoarthritis (OA) aged between 50 and 85 years, comparing clinical outcomes (pain-free function, quality of life (QoL), range of motion (ROM), and rate of post-procedural complications) and cost-effectiveness. TARVA is a clinician-led, pragmatic, superiority trial designed to compare the improvement in pain-free function, as assessed by the Manchester-Oxford Foot Questionnaire (MOXFQ) walking/standing domain score from pre-op to 52 weeks post-op for each surgical treatment group. A total of 328 patients will be randomly allocated on an equal basis to one of two surgical treatments: i) Total Ankle Replacement; and ii) Ankle Arthrodesis. Randomisation will be stratified by surgeon and presence of OA in two adjacent joints as determined by a pre-operative MRI scan.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
* 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)
* History of local bone or joint infection
* 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

Primary outcomes:
measure: Self-reported pain-free function domain score
timeFrame: Pre-operation (baseline) to 52 weeks
Secondary outcomes:
measure: Self-reported pain-free function domain score
timeFrame: Pre-operation (baseline) to 26 weeks
measure: Self-reported pain and social interaction domain score
timeFrame: Pre-operation (baseline) to 26 and 52 weeks
measure: Self-reported physical function
timeFrame: Pre-operation (baseline) to 26 and 52 weeks
measure: Self-reported quality of life
timeFrame: Pre-operation (baseline) to 26 and 52 weeks
measure: Range of Motion
timeFrame: Pre-operation (baseline) to 52 weeks
measure: Adverse events
timeFrame: 52 weeks
measure: Incremental cost and cost-effectiveness
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
state: Cornwall
city: Brighton
country: United Kingdom
facility: Brighton & Sussex University Hospitals NHS Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale Orthopaedic Centre
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital NHS Trust
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
Study officials:
affiliation: Royal National Orthopaedic Hospital NHS Trust
name: Andrew Goldberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller P, Skene SS, Chowdhury K, Cro S, Goldberg AJ, Dore CJ; TARVA Study Group. A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan. Trials. 2020 Feb 18;21(1):197. doi: 10.1186/s13063-019-3973-4.
citation: Goldberg AJ, Zaidi R, Thomson C, Dore CJ, Skene SS, Cro S, Round J, Molloy A, Davies M, Karski M, Kim L, Cooke P; TARVA study group. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Sep 6;6(9):e012716. doi: 10.1136/bmjopen-2016-012716.