Assessment of Preoperative and Postoperative Ankle Kinematics

NCT05868759 | Completed

• 1 other identifier: TAR-RSA/2020/Sper/IOR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Keywords

ankle ostearthritis; ankle prosthesis; Roentgen Stereophotogrammetric Analysis

Outcome Measures

Primary Outcomes (1)

• Roentgenstereophotogrammetric analysis

  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

  9 months

Secondary Outcomes (10)

• evaluation of range of motion (degree)

  at baseline (Day0)

• evaluation of range of motion (degree)

  9 months

• Delos Postural Proprioceptive System

  at baseline (Day0)

• Delos Postural Proprioceptive System

  9 months

• modified Star Excursional Balance Test (mSEBT) functional test

  at baseline (day 0)

Study Arms (1)

patients

EXPERIMENTAL

Candidates for an ankle prosthesis

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)

Interventions

Roentgen Stereophotogrammetric Analysis (RSA) RADIATION

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".

patients

Delos Postural Proprioceptive System (computerized oscillating platform) DEVICE

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

patients

Modified Star Excursional Balance Tests DIAGNOSTIC_TEST

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.

patients

Inertial sensors Xsens MVN DEVICE

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.

patients

American Orthopaedic Foot and Ankle Score (AOFAs) OTHER

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.

patients

Visual Analogue Scale (VAS) OTHER

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.

patients

12-Item Short Form Survey (SF-12) OTHER

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.

patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, BO, 40126, Italy

Location

Related Publications (4)

• Riva D, Bianchi R, Rocca F, Mamo C. Proprioceptive Training and Injury Prevention in a Professional Men's Basketball Team: A Six-Year Prospective Study. J Strength Cond Res. 2016 Feb;30(2):461-75. doi: 10.1519/JSC.0000000000001097.

  PMID: 26203850 RESULT

• Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.

  PMID: 22892416 RESULT

• Gougoulias NE, Khanna A, Maffulli N. History and evolution in total ankle arthroplasty. Br Med Bull. 2009;89:111-51. doi: 10.1093/bmb/ldn039. Epub 2008 Nov 13.

  PMID: 19008282 RESULT

• Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.

  PMID: 2686344 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: May 22, 2023
• Study Start: July 28, 2020
• Primary Completion: May 13, 2021
• Study Completion: June 1, 2022
• Last Updated: May 22, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)