Total Ankle Replacement Versus Arthrodesis Trial (TARVA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT02128555
First received: April 11, 2014
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention
Osteoarthritis
Procedure: Total Ankle Replacement
Procedure: Arthrodesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Self-reported pain-free function domain score [ Time Frame: Pre-operation (baseline) to 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-operation (baseline) to 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-operation (baseline) to 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-operation (baseline) to 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-operation (baseline) to 26 and 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-operation (baseline) to 52 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    To compare the safety of TAR versus arthrodesis in terms of complications and adverse events.

  • Incremental cost and cost-effectiveness [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 328
Study Start Date: July 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
  • 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)
  • Significant deformity (>20 degrees at tibiotalar joint) on standing films
  • Ligamentous disruption (with clinical instability)
  • Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
  • Poorly controlled diabetes (HbA1c>9)
  • Poor vascular supply of soft tissue envelope
  • >15% avascular necrosis (AVN) of the talus
  • History of local infection
  • Pregnancy (in women of childbearing potential)
  • Severe osteoporosis (T Score <-2.5) with recent fracture (<12 months)
  • Any co-morbidity, (e.g., diabetes, heart condition, obesity, active cancer, psychiatric illness, hypermobility syndrome etc.) 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
  • The patient has participated in a clinical trial and has had an investigational medicinal product (IMP) administered within the last 3 months, or is currently participating in a clinical trial of a medical device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128555

Locations
United Kingdom
Royal National Orthopaedic Hospital NHS Trust Not yet recruiting
Stanmore, United Kingdom, HA7 4LP
Contact: Deirdre Brooking       deirdre.brooking@rnoh.nhs.uk   
Principal Investigator: Andrew J Goldberg, MBBS MD FRCS         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Andrew Goldberg Royal National Orthopaedic Hospital NHS Trust
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02128555     History of Changes
Obsolete Identifiers: NCT01518361
Other Study ID Numbers: 12/0518, 12/35/27, ISRCTN60672307, U1111-1157-4155
Study First Received: April 11, 2014
Last Updated: May 29, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

Keywords provided by University College, London:
ankle arthritis
osteoarthritis
total ankle replacement
arthrodesis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014