An interventional study of early mobilizzation of the ankle in Ankle Osteoarthritis, Ankle - Recurrent Dislocation and Cartilage Disease, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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
74 studies on the registry are indexed under Cartilage Diseases; 6 are open to participants now.
This study's planned enrollment of 72 is above the median of 48 across 50 interventional studies indexed under Cartilage Diseases.
Browse Cartilage Diseases studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
first metatarsal bone, supramalleolar osteotomy, etc.)
early motion of the ankle
Procedure: early mobilizzation of the ankle
standard treatment
Procedure: early mobilizzation of the ankle
perform flexion-extension exercises of the operated ankle
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
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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°
Time frame: 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).
Time frame: 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.
Time frame: 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%
Time frame: 3, 6 weeks, 3 - 6 - 9 - 12 - 24 month from the surgery
Plan to share: Undecided
Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.
Of 17 interventional studies with no phase under Cartilage Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 61. This study's planned 24 months is close to that.
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