TARVA: Total Ankle Replacement Versus Arthrodesis Trial

Sponsor

University College, London (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02128555

Collaborator

National Institute for Health Research, United Kingdom (Other)

303

Enrollment

Locations

Arms

169.9

Anticipated Duration (Months)

17.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Procedure: Total Ankle Replacement Procedure: Arthrodesis	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

303 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 23, 2019

Anticipated Study Completion Date :

Feb 28, 2029

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arthrodesis Ankle arthrodesis (fusion)	Procedure: Arthrodesis 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. Other Names: Fusion
Experimental: Total Ankle Replacement Total Ankle Replacement	Procedure: Total Ankle Replacement The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.

Arm

Intervention/Treatment

Active Comparator: Arthrodesis

Ankle arthrodesis (fusion)

Procedure: Arthrodesis

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.

Other Names:

Fusion

Experimental: Total Ankle Replacement

Total Ankle Replacement

Procedure: Total Ankle Replacement

The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.

Outcome Measures

Primary Outcome Measures

Self-reported pain-free function domain score [Pre-operation (baseline) to 52 weeks]
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 [Pre-operation (baseline) to 26 weeks]
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 [Pre-operation (baseline) to 26 and 52 weeks]
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 [Pre-operation (baseline) to 26 and 52 weeks]
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 [Pre-operation (baseline) to 26 and 52 weeks]
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 [Pre-operation (baseline) to 52 weeks]
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 [52 weeks]
To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.
Incremental cost and cost-effectiveness [52 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Cornwall Hospitals NHS Trust	Truro	Cornwall	United Kingdom	TR1 3LQ
2	Brighton & Sussex University Hospitals NHS Trust	Brighton		United Kingdom
3	North Bristol NHS Trust	Bristol		United Kingdom
4	Cardiff and Vale Orthopaedic Centre	Cardiff		United Kingdom
5	Royal Derby Hospital	Derby		United Kingdom	DE22 3NE
6	Royal Surrey County Hospital	Guildford		United Kingdom	GU2 7XX
7	Hull and East Yorkshire Hospitals NHS Trust	Hull		United Kingdom
8	Aintree University Hospital	Liverpool		United Kingdom	L9 7AL
9	Freeman Hospital	Newcastle		United Kingdom	NE7 7DN
10	Northumbria Healthcare NHS Foundation Trust	Newcastle		United Kingdom
11	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich		United Kingdom
12	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom
13	Robert Jones & Agnes Hunt Orthopaedic Hospital	Oswestry		United Kingdom	SY10 7AG
14	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom	OX3 7LD
15	Northern General Hospital	Sheffield		United Kingdom	S5 7AU
16	Royal National Orthopaedic Hospital NHS Trust	Stanmore		United Kingdom	HA7 4LP
17	Wrightington Hospital	Wigan		United Kingdom	WN6 9EP