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Assessment of Preoperative and Postoperative Ankle Kinematics (TAR-RSA)

Primary Purpose

Ankle Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Roentgen Stereophotogrammetric Analysis (RSA)
Delos Postural Proprioceptive System (computerized oscillating platform)
Modified Star Excursional Balance Tests
Inertial sensors Xsens MVN
American Orthopaedic Foot and Ankle Score (AOFAs)
Visual Analogue Scale (VAS)
12-Item Short Form Survey (SF-12)
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Osteoarthritis focused on measuring ankle ostearthritis, ankle prosthesis, Roentgen Stereophotogrammetric Analysis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rizzoli Orthopaedic Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

Candidates for an ankle prosthesis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2022
Last Updated
May 19, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05868759
Brief Title
Assessment of Preoperative and Postoperative Ankle Kinematics
Acronym
TAR-RSA
Official Title
Assessment of Preoperative and Postoperative Ankle Kinematics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Osteoarthritis
Keywords
ankle ostearthritis, ankle prosthesis, Roentgen Stereophotogrammetric Analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
Candidates for an ankle prosthesis
Intervention Type
Radiation
Intervention Name(s)
Roentgen Stereophotogrammetric Analysis (RSA)
Intervention Description
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".
Intervention Type
Device
Intervention Name(s)
Delos Postural Proprioceptive System (computerized oscillating platform)
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Modified Star Excursional Balance Tests
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Inertial sensors Xsens MVN
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
American Orthopaedic Foot and Ankle Score (AOFAs)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Visual Analogue Scale (VAS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
12-Item Short Form Survey (SF-12)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Roentgenstereophotogrammetric analysis
Description
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
9 months
Secondary Outcome Measure Information:
Title
evaluation of range of motion (degree)
Description
motion tracker
Time Frame
at baseline (Day0)
Title
evaluation of range of motion (degree)
Description
motion tracker
Time Frame
9 months
Title
Delos Postural Proprioceptive System
Description
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 (Day0)
Title
Delos Postural Proprioceptive System
Description
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
Title
modified Star Excursional Balance Test (mSEBT) functional test
Description
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 (day 0)
Title
modified Star Excursional Balance Test (mSEBT) functional test
Description
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
Title
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Description
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Time Frame
at baseline (Day0)
Title
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Description
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Time Frame
9 months
Title
Short Form Health Survey - 12 questionnaire
Description
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Time Frame
at baseline (Day0)
Title
Short Form Health Survey - 12 questionnaire
Description
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
State/Province
BO
ZIP/Postal Code
40126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26203850
Citation
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.
Results Reference
result
PubMed Identifier
22892416
Citation
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.
Results Reference
result
PubMed Identifier
19008282
Citation
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.
Results Reference
result
PubMed Identifier
2686344
Citation
Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.
Results Reference
result

Learn more about this trial

Assessment of Preoperative and Postoperative Ankle Kinematics

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