Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2023-10-31
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Customized and Standard Total Ankle Prostheses
NCT06193057
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
NCT02025946
Total Ankle Replacement: Clinical and Radiological Outcomes
NCT03650010
Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement
NCT06462625
Assessment of Preoperative and Postoperative Ankle Kinematics
NCT05868759
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mobilizzazione Precoce
early motion of the ankle
early mobilizzation of the ankle
perform flexion-extension exercises of the operated ankle
Immobilizzazione Con Stivaletto Gessato
standard treatment
early mobilizzation of the ankle
perform flexion-extension exercises of the operated ankle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
early mobilizzation of the ankle
perform flexion-extension exercises of the operated ankle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Mazzotti
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istituto Ortopedico Rizzoli
Bologna, Italia, Italy
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EMOTAA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.