Total Ankle Replacement Versus Arthrodesis (TARVA) Trial

Not Applicable

Completed

• Conditions: Osteoarthritis; Musculoskeletal Diseases; Generalized osteoarthritis NOS

• Registration Number: ISRCTN60672307
• Lead Sponsor: niversity College London (UCL) (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-12
• Study Completion: 2018-05-14
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 303

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
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

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)
3. Significant deformity (>20 degrees at tibiotalar joint) on standing films
4. Ligamentous disruption (with clinical instability)
5. Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
6. Poorly controlled diabetes (HbA1c>9)
7. Poor vascular supply or soft tissue envelope
8. Above 15% AVN of the talus
9. History of local infection
10. Pregnancy (in women of childbearing potential)
11. Severe osteoporosis (T Score <-2.5) with recent fracture (<12 months)
12. 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
13. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified