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Total Ankle Replacement Versus Arthrodesis Trial (TARVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02128555
Recruitment Status : Unknown
Verified October 2017 by University College, London.
Recruitment status was:  Recruiting
First Posted : May 1, 2014
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 328 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 : January 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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.




Primary Outcome Measures :
  1. Self-reported pain-free function domain score [ Time Frame: 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 :
  1. Self-reported pain-free function domain score [ Time Frame: 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.

  2. Self-reported pain and social interaction domain score [ Time Frame: 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.

  3. Self-reported physical function [ Time Frame: 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.

  4. Self-reported quality of life [ Time Frame: 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.

  5. Range of Motion [ Time Frame: 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.

  6. Adverse events [ Time Frame: 52 weeks ]
    To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.

  7. Incremental cost and cost-effectiveness [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128555


Contacts
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Contact: Deirdre Brooking 020 8385 3402 deirdre.brooking@rnoh.nhs.uk

Locations
Show Show 17 study locations
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Andrew Goldberg Royal National Orthopaedic Hospital NHS Trust
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02128555    
Obsolete Identifiers: NCT01518361
Other Study ID Numbers: 12/0518
12/35/27 ( Other Grant/Funding Number: NIHR HTA )
ISRCTN60672307 ( Registry Identifier: ISRCTN )
U1111-1157-4155 ( Registry Identifier: Universal Trial Number )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by University College, London:
ankle arthritis
osteoarthritis
total ankle replacement
arthrodesis
quality of life
musculoskeletal
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases