Early MOtion Total Ankle Artroplasty

Not Applicable

Recruiting

• Conditions: Ankle Arthropathy; Ankle - Recurrent Dislocation; Cartilage Disease; Ankle Osteoarthritis

• Registration Number: NCT06525545
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MOXFQ	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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.
SF-36 Questionnaire o Short Form-36 Health Survey	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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).
VAS	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	A Visual Analogue Scale (VAS) is a pain rating scales and ranges from 0 to 10 points
STTA - Sagittal TibioTalar Angle	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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
AOFAS score	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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
Hindfoot Alignment - Saltzman view mesurament	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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
Lateral distal tibial angle - LDTA	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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
Anterior distal tibial angle - ADTA	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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
Center of Rotation of Angulation CORA	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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).
Tibio-Talar Angle - TTA	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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°
Gamma Angle	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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.
T-T ratio (Tibio-talar Ratio)	3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery	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%

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italia, Italy