Ankle OsteoarthritisTAR-RSANCT05868759
Assessment of Preoperative and Postoperative Ankle Kinematics
A study testing Roentgen Stereophotogrammetric Analysis (RSA), Delos Postural Proprioceptive System (computerized oscillating platform) and Modified Star Excursional Balance Tests in people with Ankle Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- Roentgen Stereophotogrammetric Analysis (RSA), Delos Postural Proprioceptive System (computerized oscillating platform) and Modified Star Excursional Balance Tests
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 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)
- Keywords
- ankle ostearthritis, ankle prosthesis, Roentgen Stereophotogrammetric Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
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
Modified Star Excursional Balance TestsDiagnostic 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.
Inertial sensors Xsens MVNDevice
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)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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Candidates for an ankle prosthesis Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (10)
evaluation of range of motion (degree)
motion tracker
Measured: at baseline (Day0)
evaluation of range of motion (degree)
motion tracker
Measured: 9 months
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
Measured: at baseline (Day0)
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
Measured: 9 months
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
Measured: at baseline (day 0)
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
Measured: 9 months
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Measured: at baseline (Day0)
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Measured: 9 months
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.
Measured: at baseline (Day0)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start28 Jul 2020
- Primary completion13 May 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano Mosca, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868759
- Sponsor's protocol ID
- TAR-RSA/2020/Sper/IOR
- Acronym
- TAR-RSA
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26203850Gribble 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.
PubMed 22892416Gougoulias 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.
PubMed 19008282Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.
PubMed 2686344
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Preoperative and Postoperative Ankle Kinematics
- ClinicalTrials.gov ID
- NCT05868759
- Acronym / sponsor ID
- TAR-RSA / TAR-RSA/2020/Sper/IOR
- Conditions
- Ankle Osteoarthritis
- Keywords
- ankle ostearthritis, ankle prosthesis, Roentgen Stereophotogrammetric Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | 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)Candidates for an ankle prosthesis |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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". | Radiation | patients |
| 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 | Device | patients |
| Modified Star Excursional Balance TestsThe 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. | Diagnostic test | patients |
| Inertial sensors Xsens MVNThe 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. | Device | patients |
| 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 | patients |
| 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 | patients |
| 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. | Other | patients |
Primary outcome
Roentgenstereophotogrammetric analysis
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
10 secondary outcomes
evaluation of range of motion (degree)
Time frame: at baseline (Day0)
evaluation of range of motion (degree)
Time frame: 9 months
Delos Postural Proprioceptive System
Time frame: at baseline (Day0)
Delos Postural Proprioceptive System
Time frame: 9 months
modified Star Excursional Balance Test (mSEBT) functional test
Time frame: at baseline (day 0)
modified Star Excursional Balance Test (mSEBT) functional test
Time frame: 9 months
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Time frame: at baseline (Day0)
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Time frame: 9 months
Short Form Health Survey - 12 questionnaire
Time frame: at baseline (Day0)
Short Form Health Survey - 12 questionnaire
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Results publication: PubMed 26203850Riva 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 publication: PubMed 22892416Gribble 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 publication: PubMed 19008282Gougoulias 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 publication: PubMed 2686344Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1-51.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roentgen Stereophotogrammetric Analysis (RSA), Delos Postural Proprioceptive System (computerized oscillating platform) and Modified Star Excursional Balance Tests in people with Ankle Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roentgenstereophotogrammetric analysis (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.