Assessment of Preoperative and Postoperative Ankle Kinematics

Not Applicable

Completed

• Conditions: Ankle Osteoarthritis
• Interventions: Radiation: Roentgen Stereophotogrammetric Analysis (RSA); Device: Delos Postural Proprioceptive System (computerized oscillating platform); Diagnostic Test: Modified Star Excursional Balance Tests; Device: Inertial sensors Xsens MVN; Other: American Orthopaedic Foot and Ankle Score (AOFAs); Other: Visual Analogue Scale (VAS); Other: 12-Item Short Form Survey (SF-12)

• Registration Number: NCT05868759
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Study Timeline

• Study Start: 2020-07-28
• Primary Completion: 2021-05-13
• Status Verified: 2022-05
• Study First Submitted: 2022-05-26
• Study Completion: 2022-06-01
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Candidates for ankle prosthesis
• Potential party able to provide informed consent and sign the approved Informed Consent Form;
• Male or female patients aged 40 to 80;
• Patients available to perform post-operative rehabilitation according to standard protocol, follow-up visits and radiological investigations scheduled for follow-up up up up to 24 months. In addition, patients who are available to perform all study tests, preoperators and follow-up.

Exclusion Criteria

• Previous total prosthetic replacement of the ankle (revision surgery);
• Severe pre-operative deformity in valgus or varus (>10 sanguine); BMI>40 kg/m2;
• Pre-existing abnormalities of walking kinematics (amputations, neuro-muscular diseases, polio, hip dysplasia);
• Severe arthrosis of the knee (Kellgren-Lawrence>3);
• Severa coxartrosi (Kellgren-Lawrence>3);
• Previous hip and/or knee prosthesis surgery;
• Total avascular astragalus necrosis or other severe bone loss of the ankle that makes the implantation of standard prosthetic components contraindicated;
• Pregnancy confirmed by positive hcg serum or in vitro diagnostic test or ongoing breastfeeding;
• Active or latent infection of the affected ankle joint or any other systemic infection being treated;
• History of alcoholism, drug or substance abuse intravenously, psychosis, personality disorder/s, poor motivation, emotional or intellectual problems that could make the potential subject unstable for participation in the trial, or any combination of variables which in the opinion of the Principal Investigator should exclude the potential subject;
• Clinically documented acute or chronic pathology, other than the indication for the treatment adopted in this Trial, which could affect life expectancy or make it difficult to interpret the outcome of the potential subject in accordance with the Protocol (e.g., renal, hepatic, cardiac, endocrine, haematological, autoimmune, bone metabolism, crystal deposits or neoplasms);
• Potential subjects with medical conditions that interfere with the ability to participate in a standardized rehabilitation program;
• Participation in any other trial of another drug or experimental device within 60 days prior to the screening visit or administration of that drug or device during the course of this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	Roentgen Stereophotogrammetric Analysis (RSA)	Candidates for an ankle prosthesis
patients	American Orthopaedic Foot and Ankle Score (AOFAs)	Candidates for an ankle prosthesis
patients	Modified Star Excursional Balance Tests	Candidates for an ankle prosthesis
patients	Inertial sensors Xsens MVN	Candidates for an ankle prosthesis
patients	12-Item Short Form Survey (SF-12)	Candidates for an ankle prosthesis
patients	Delos Postural Proprioceptive System (computerized oscillating platform)	Candidates for an ankle prosthesis
patients	Visual Analogue Scale (VAS)	Candidates for an ankle prosthesis

Primary Outcome Measures

Name	Time	Method
Roentgenstereophotogrammetric analysis	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

Secondary Outcome Measures

Name	Time	Method
evaluation of range of motion (degree)	9 months	motion tracker
modified Star Excursional Balance Test (mSEBT) functional test	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
Delos Postural Proprioceptive System	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
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire	9 months	AOFAs: values from 0 to 100 dependent on limitations in performing activities
Short Form Health Survey - 12 questionnaire	9 months	SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, BO, Italy