Early MOtion Total Ankle Artroplasty

NCT06525545 | Recruiting DMC

• 1 other identifier: EMOTAA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Ankle Osteoarthritis; Ankle - Recurrent Dislocation; Cartilage Disease; Ankle Arthropathy

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Mobilizzazione Precoce

EXPERIMENTAL

early motion of the ankle

Procedure: early mobilizzation of the ankle

Immobilizzazione Con Stivaletto Gessato

ACTIVE COMPARATOR

standard treatment

Procedure: early mobilizzation of the ankle

Interventions

early mobilizzation of the ankle PROCEDURE

perform flexion-extension exercises of the operated ankle

Immobilizzazione Con Stivaletto Gessato; Mobilizzazione Precoce

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italia, 40135, Italy

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: interventional randomized case control

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: October 31, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

IT (1)