Clinical trial NCT06525545: Early MOtion Total Ankle Artroplasty
Official title: Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Osteoarthritis
Ankle - Recurrent Dislocation
Cartilage Disease
Ankle Arthropathy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional randomized case control
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: AOFAS score
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: MOXFQ
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: SF-36 Questionnaire o Short Form-36 Health Survey
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: VAS
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: STTA - Sagittal TibioTalar Angle
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Hindfoot Alignment - Saltzman view mesurament
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Lateral distal tibial angle - LDTA
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Anterior distal tibial angle - ADTA
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Tibio-Talar Angle - TTA
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Center of Rotation of Angulation CORA
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: Gamma Angle
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
measure: T-T ratio (Tibio-talar Ratio)
timeFrame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Italia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.