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Total Ankle Replacement Versus Arthrodesis Trial (TARVA)

Primary Purpose

Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total Ankle Replacement
Arthrodesis
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring ankle arthritis, osteoarthritis, total ankle replacement, arthrodesis, quality of life, musculoskeletal

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Cornwall Hospitals NHS Trust
  • Brighton & Sussex University Hospitals NHS Trust
  • North Bristol NHS Trust
  • Cardiff and Vale Orthopaedic Centre
  • Royal Derby Hospital
  • Royal Surrey County Hospital
  • Hull and East Yorkshire Hospitals NHS Trust
  • Aintree University Hospital
  • Freeman Hospital
  • Northumbria Healthcare NHS Foundation Trust
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Robert Jones & Agnes Hunt Orthopaedic Hospital
  • Oxford University Hospitals NHS Foundation Trust
  • Northern General Hospital
  • Royal National Orthopaedic Hospital NHS Trust
  • Wrightington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arthrodesis

Total Ankle Replacement

Arm Description

Ankle arthrodesis (fusion)

Total Ankle Replacement

Outcomes

Primary Outcome Measures

Self-reported pain-free function domain score
To compare the improvement in self-reported pain-free function domain score from pre-op to 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores.

Secondary Outcome Measures

Self-reported pain-free function domain score
To compare the improvement in self-reported pain-free function domain score from pre-op to 26 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores.
Self-reported pain and social interaction domain score
To compare the improvement in self-reported pain and social interaction domain scores from pre-op to 26 and 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ.
Self-reported physical function
To compare the improvement in self-reported physical function from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by the Foot and Ankle Ability Measure (FAAM) questionnaire.
Self-reported quality of life
To compare the improvement in QoL from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by EQ-5D.
Range of Motion
To compare the change in total ROM (plantarflexion and dorsiflexion) from pre-op to 52 weeks post-op of TAR versus arthrodesis, assessed by goniometer.
Adverse events
To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.
Incremental cost and cost-effectiveness
To compare the incremental cost and cost-effectiveness of TAR versus arthrodesis by recording cost of all components and procedure-related costs for each surgical treatment, and using self-reported data from the Health and Social Care Services Use questionnaire.

Full Information

First Posted
April 11, 2014
Last Updated
March 12, 2021
Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02128555
Brief Title
Total Ankle Replacement Versus Arthrodesis Trial
Acronym
TARVA
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
February 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
ankle arthritis, osteoarthritis, total ankle replacement, arthrodesis, quality of life, musculoskeletal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthrodesis
Arm Type
Active Comparator
Arm Description
Ankle arthrodesis (fusion)
Arm Title
Total Ankle Replacement
Arm Type
Experimental
Arm Description
Total Ankle Replacement
Intervention Type
Procedure
Intervention Name(s)
Total Ankle Replacement
Intervention Description
The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.
Intervention Type
Procedure
Intervention Name(s)
Arthrodesis
Other Intervention Name(s)
Fusion
Intervention Description
The remaining damaged cartilage is removed from the ends of the bone and the two bones are then held together in compression using screws, or plates until they join to become one (bone fusion), so that there is no longer any movement at that joint.
Primary Outcome Measure Information:
Title
Self-reported pain-free function domain score
Description
To compare the improvement in self-reported pain-free function domain score from pre-op to 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores.
Time Frame
Pre-operation (baseline) to 52 weeks
Secondary Outcome Measure Information:
Title
Self-reported pain-free function domain score
Description
To compare the improvement in self-reported pain-free function domain score from pre-op to 26 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ walking/standing domain scores.
Time Frame
Pre-operation (baseline) to 26 weeks
Title
Self-reported pain and social interaction domain score
Description
To compare the improvement in self-reported pain and social interaction domain scores from pre-op to 26 and 52 weeks post-op for TAR versus arthrodesis, assessed by MOXFQ.
Time Frame
Pre-operation (baseline) to 26 and 52 weeks
Title
Self-reported physical function
Description
To compare the improvement in self-reported physical function from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by the Foot and Ankle Ability Measure (FAAM) questionnaire.
Time Frame
Pre-operation (baseline) to 26 and 52 weeks
Title
Self-reported quality of life
Description
To compare the improvement in QoL from pre-op to 26 and 52 weeks post-op of TAR versus arthrodesis, assessed by EQ-5D.
Time Frame
Pre-operation (baseline) to 26 and 52 weeks
Title
Range of Motion
Description
To compare the change in total ROM (plantarflexion and dorsiflexion) from pre-op to 52 weeks post-op of TAR versus arthrodesis, assessed by goniometer.
Time Frame
Pre-operation (baseline) to 52 weeks
Title
Adverse events
Description
To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.
Time Frame
52 weeks
Title
Incremental cost and cost-effectiveness
Description
To compare the incremental cost and cost-effectiveness of TAR versus arthrodesis by recording cost of all components and procedure-related costs for each surgical treatment, and using self-reported data from the Health and Social Care Services Use questionnaire.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Goldberg
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Cornwall Hospitals NHS Trust
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom
Facility Name
Brighton & Sussex University Hospitals NHS Trust
City
Brighton
Country
United Kingdom
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Cardiff and Vale Orthopaedic Centre
City
Cardiff
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Newcastle
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Robert Jones & Agnes Hunt Orthopaedic Hospital
City
Oswestry
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
Facility Name
Wrightington Hospital
City
Wigan
ZIP/Postal Code
WN6 9EP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32070409
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.
Results Reference
derived
PubMed Identifier
27601503
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.
Results Reference
derived
Links:
URL
http://www.anklearthritis.co.uk
Description
TARVA website

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Total Ankle Replacement Versus Arthrodesis Trial

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