Rizzoli Orthopaedic Institute
Bologna, BO, 40126, Italy
NCT Number: NCT05868759
The objective is to study the joint kinematics of the prosthetic implant, in terms of translation, rotation, Range of motion and proprioception, in patients treated for prosthetic replacement of the ankle, quantitatively and under physiological load conditions.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Bologna, BO, 40126, Italy
Patients will be subjected to the same tests at zero time and 9 months after the implantation of the prosthesis, except for RSA which will be performed only 9 months after the surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Roentgenstereophotogrammetric analysis (RSA) is a radiographic technique, highly accurate both to evaluate the primary stability of the implant, then the micromovements between bone and implant prosthetic, both for the evaluation of the kinematics of the prosthetic components. The RSA technique in dynamics is able to obtain, with patient in motion, a series of radiographic frames in sequence in two projections, which are captured simultaneously. Each pair of orthogonal projections corresponds to a specific moment of the movement carried out by the patient and will be used to obtain, through dedicated software, a reconstruction three-dimensional instant defined "RSA scenes".
The Delos Postural Proprioceptive System uses electronic tilting tables (on a single axis or three axes) with high frequency that allows very short stop and reversal times that allow both to study the proprioception and the patient's response to the modification of movement of the inclined plane
The Star Excursional Balance Test (SEBT) is a clinical test designed for the evaluation of dynamic physical performance of the tibiotarsica. The first literary references date back to 1998 and the test, remaining in balance with the ankle in the studio, the achievement of the maximum possible distance with the contralateral foot along well-defined axes.
The inertial motion acquisition system Xsens MVN is easy to use and economic to detect the movement of different anatomical districts. MVN is based on inertial sensors in miniature through communication solutions combined with advanced fusion algorithms sensors, using hypotheses of biomechanical models.
This MVN system is a system of inertial kinematic measurement of the whole body, which incorporates synchronized data. Instant graphic output is provided, including angles of motion articular.
American Orthopaedic Foot and Ankle Score (AOFAs) is a clinical trial commonly used in scientific literature which serves to assess, in terms of value from 0 to 100, the autonomy, pain, stability, ankle alignment and back foot of the patient.
The Visual Analogue Scale (VAS) is a visual representation of the extent of pain that the patient subjectively warns. The VAS is represented by a 10 cm long line in the original version validated, with or without notches at each centimeter. One end indicates the absence of pain and corresponds to 0, the other end indicates the worst pain imaginable and corresponds to 10.
The 12-Item Short Form Survey (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life.
Time frame: 9 months
Roentgenstereophotogrammetric analysis (RSA) is a radiographic technique, highly accurate both to assess the primary stability of the implant, and therefore the micromovements between bone and prosthetic implant, and for the evaluation of the kinematics of the prosthetic components.
Using reference points it is possible to measure the micro-movements that occur between several contiguous elements
Time frame: at baseline (Day0)
motion tracker
Time frame: 9 months
motion tracker
Time frame: at baseline (Day0)
The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population
Time frame: 9 months
The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population
Time frame: at baseline (day 0)
mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground
Time frame: 9 months
mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground
Time frame: at baseline (Day0)
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Time frame: 9 months
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Time frame: at baseline (Day0)
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Time frame: 9 months
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Istituto Ortopedico Rizzoli
Other
Acronym: TAR-RSA
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