Early MOtion Total Ankle Artroplasty (EMOTAA)

Comparison of Clinical and Radiological Results of Patients Undergoing Total Ankle Arthroplasty and Treated With Early Mobilization or With Cast Immobilization

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

Study Overview

• Status: Recruiting
• Conditions: Cartilage Disease; Ankle Osteoarthritis; Ankle Arthropathy; Ankle - Recurrent Dislocation
• Intervention / Treatment: Procedure: early mobilizzation of the ankle

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italia
    • Bologna, Italia, Italy, 40135
      • Recruiting
      • Istituto Ortopedico Rizzoli
      • Contact: Antonio Mazzotti, MD, PhD; Phone Number: +39 051 636 6111; Email: antonio.mazzotti@ior.it
      • Contact: Phone Number: +39 051 636 6111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobilizzazione Precoce; early motion of the ankle	Procedure: early mobilizzation of the ankle; perform flexion-extension exercises of the operated ankle
Active Comparator: Immobilizzazione Con Stivaletto Gessato; standard treatment	Procedure: early mobilizzation of the ankle; perform flexion-extension exercises of the operated ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS score	The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
MOXFQ	The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
SF-36 Questionnaire o Short Form-36 Health Survey	The 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self- erception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental)The scores range from 0 point (best) to 100 (worst).	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
VAS	A Visual Analogue Scale (VAS) is a pain rating scales and ranges from 0 to 10 points	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
STTA - Sagittal TibioTalar Angle	In a lateral weight-bearing radiograph, the saggittal Tibio Talar Angle is the angke between the rantomica axis of the tibia and the he longitudinal axis of the talus, this is determined by drawing a line connecting the midpoints of a line bisecting the talar neck and another line bisecting the talar body	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Hindfoot Alignment - Saltzman view mesurament	On the saltzman radiologial view is calculated thedistance between the axis of the tibia shaft and the contact point of the heel. Normal values -3 ± 7 mm	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Lateral distal tibial angle - LDTA	Lateral distal tibia angle (LDTA) is measured between the mid-diaphyseal line of the tibia and the line parallel to the distal tibial plafond. The lateral distal tibial angle has a norm of 89 degrees ± 3 degrees	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Anterior distal tibial angle - ADTA	The ADTA is formed by the mechanical axis of the tibia and the joint orientation line of the ankle in the sagittal plane and measures 80° ± 3° in the normal lower extremity	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Tibio-Talar Angle - TTA	The tibiotalar angle is between the anatomic axis of the tibia and the superior articular surface of the talar dome. The mean and standard deviation are: 88.7° ± 5.1°	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Center of Rotation of Angulation CORA	The CORA is the intersection of the mid-diaphyseal line and the line starting from the middle of the joint and perpendicular to the abnormal ADTA or LDTA. The CORA can be located at the joint line level (usually due to anatomical joint line malalignment or to ankle degeneration) or proximally (usually due to tibial deformities/fractures).	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Gamma Angle	Gamma angle (γ) is formed by intersection of line drawn through long axis of talar component with line drawn from posterior talar component through middle of talar neck.	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
T-T ratio (Tibio-talar Ratio)	Tibiotalar ratio (TT ratio). A talar reference line is drawn parallel to the floor from the posterior talar point (defined as the intersection between the posterosuperior calcaneal cortex and the posterior subtalar articular surface) to the anterior talar point (vertical projection of the most anterior point of the talus onto the talar reference line). Next, the distal tibial axis is the line drawn between the midpoint of the distal tibial shaft measured 5 and 10 cm above the ankle. This divides the talar reference line into anterior and posterior segments. The TT ratio is the ratio of the length of the posterior segment of the talus (AC) to the longitudinal talar length (AB), expressed as a percentage. Normal value, 27% to 42%	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: EMOTAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No