NCT05868759

Assessment of Preoperative and Postoperative Ankle Kinematics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ankle Osteoarthritis

Interventions

Type	Name	Description
RADIATION	Roentgen Stereophotogrammetric Analysis (RSA)	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".
DEVICE	Delos Postural Proprioceptive System (computerized oscillating platform)	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
DIAGNOSTIC_TEST	Modified Star Excursional Balance Tests	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.
DEVICE	Inertial sensors Xsens MVN	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.
OTHER	American Orthopaedic Foot and Ankle Score (AOFAs)	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.
OTHER	Visual Analogue Scale (VAS)	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.
OTHER	12-Item Short Form Survey (SF-12)	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.

Timeline

• Start date: 2020-07-28
• Primary completion: 2021-05-13
• Completion: 2022-06-01
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

1 site across 1 country: Italy