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Clinical Trials/ISRCTN60672307
ISRCTN60672307
Completed
未知

A randomised, multi-centre, non-blinded, prospective, parallel group trial of total ankle replacement (TAR) versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis, comparing clinical outcomes and cost-effectiveness

niversity College London (UCL) (UK)0 sites303 target enrollmentMay 12, 2014
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ConditionsOsteoarthritisMusculoskeletal DiseasesGeneralized osteoarthritis NOS

Overview

Phase
未知
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
niversity College London (UCL) (UK)
Enrollment
303
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27601503 protocol (added 10/04/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36375147/ (added 15/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37022932/ (added 11/04/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38189868/ Cost-utility analysis (added 09/01/2024)

Registry
who.int
Start Date
May 12, 2014
End Date
May 14, 2018
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity College London (UCL) (UK)

Eligibility Criteria

Inclusion Criteria

  • •Current inclusion criteria as of 08/10/2014:
  • •1\. Diagnosis of end\-stage ankle OA
  • •2\. Aged 50\-85 years inclusive
  • •3\. The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
  • •4\. The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
  • •5\. The patient is willing and able to provide written informed consent
  • •Previous inclusion criteria:
  • •1\. Diagnosis of end\-stage ankle OA
  • •2\. Aged 50\-85 years inclusive
  • •3\. The surgeon believes the patient is suitable for both TAR and arthrodesis

Exclusion Criteria

  • •Current exclusion criteria as of 08/10/2014:
  • •1\. Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
  • •2\. More than four lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
  • •3\. Unable to have MRI/CT scan (e.g., severe claustrophobia or contraindication for either scan)
  • •4\. History of local bone or joint infection
  • •5\. 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
  • •6\. Participant in another clinical trial that would materially impact on their participation in this study
  • •Previous exclusion criteria:
  • •1\. Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
  • •2\. More than four lower limb joints fused (including contralateral limb)

Outcomes

Primary Outcomes

Not specified

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