Recruiting NCT06525545
Early MOtion Total Ankle Artroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: early mobilizzation of the ankle.
- Who it may be relevant to
- Registry conditions: Ankle Osteoarthritis, Ankle - Recurrent Dislocation, Cartilage Disease, Ankle Arthropathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization
Overview
Evaluate the clinical and radiographic results of patients undergoing total ankle arthroplasty and treated in the post-operative period in a randomized manner with early mobilization of the ankle joint or with cast immobilization for 3 weeks
Interventions
- Procedure early mobilizzation of the ankle
perform flexion-extension exercises of the operated ankle
Primary outcome measures
- AOFAS score [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- MOXFQ [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- SF-36 Questionnaire o Short Form-36 Health Survey [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- VAS [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- STTA - Sagittal TibioTalar Angle [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- Hindfoot Alignment - Saltzman view mesurament [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- Lateral distal tibial angle - LDTA [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- Anterior distal tibial angle - ADTA [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- Tibio-Talar Angle - TTA [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
- Center of Rotation of Angulation CORA [Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery]
Eligibility criteria
Inclusion criteria
- Adult patients (aged between 18 and 80).
- Male or female patients;
- Signature of the informed consent for participation in the study;
- Patients prepared and motivated to comply with the scheduled follow-up visits and the completion of the study questionnaires
Exclusion criteria
- main diagnosis other than osteoarthritis, history of ankle infection
- need to carry out surgical interventions associated with total prosthesis ankle (e.g., calcaneal osteotomy, knee lowering osteotomy).
first metatarsal bone, supramalleolar osteotomy, etc.)
- intraoperative complications (for example a malleolar fracture) which require a different post-operative protocol
- peripheral vascular disease
- marked osteoporosis of the ankle and foot
- osteonecrosis of the talus
- neurological disorders affecting the lower limb inability to understand study information or respond to questionnaires due to cognitive or linguistic deficits
- patients who are pregnant or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Publications
- Hintermann B, Knupp M, Zwicky L, Barg A. Total ankle replacement for treatment of end-stage osteoarthritis in elderly patients. J Aging Res. 2012;2012:345237. doi: 10.1155/2012/345237. Epub 2012 Jun 5. PMID 22720158
- Giannini S, Romagnoli M, O'Connor JJ, Catani F, Nogarin L, Magnan B, Malerba F, Massari L, Guelfi M, Milano L, Volpe A, Rebeccato A, Leardini A. Early clinical results of the BOX ankle replacement are satisfactory: a multicenter feasibility study of 158 ankles. J Foot Ankle Surg. 2011 Nov-Dec;50(6):641-7. doi: 10.1053/j.jfas.2011.06.003. Epub 2011 Aug 15. PMID 21840736
- Mosca M, Caravelli S, Vocale E, Maitan N, Grassi A, Massimi S, Fuiano M, Zaffagnini S. Clinical-radiological outcomes and complications after total ankle replacement through a lateral transfibular approach: a retrospective evaluation at a mid-term follow-up. Int Orthop. 2021 Feb;45(2):437-443. doi: 10.1007/s00264-020-04709-4. Epub 2020 Jul 14. PMID 32666242
- Onggo JR, Nambiar M, Phan K, Hickey B, Galvin M, Bedi H. Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis. Foot Ankle Surg. 2020 Jul;26(5):556-563. doi: 10.1016/j.fas.2019.07.006. Epub 2019 Jul 25. PMID 31420116
- Izzo A, Di Gennaro D, Sgadari A, Coviello A, Marasco D, Balato G, Mariconda M, Bernasconi A. Periprosthetic joint infection in total ankle replacement: which are the current diagnostic criteria? Acta Biomed. 2023 Aug 3;94(4):e2023105. doi: 10.23750/abm.v94i4.14082. PMID 37539613
Identifiers
NCT: NCT06525545 · EMOTAA