Ankle Osteoarthritis (AO-IFAB)

May 16, 2017 updated by: Hospices Civils de Lyon

Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics

Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by severe pain, loss of autonomy, diminished health-related quality of life, functional disability and diminished physical ability to fulfill occupational duties of life in its end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and total ankle replacement. Despite the good pain relief provided by these procedures, patients are still experiencing post-operatively important functional limitations in their activities of the daily living which affect their independency and quality of life. In order to remain capable of performing primary activities of the daily living, those patients have to make functional compensatory adaptations in the ipsilateral adjacent joints that will cause additional degenerative joint disease in those joints.

Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic and questionnaire outcomes. However, these outcome measures have been criticized for not being sensitive enough to detect clinically meaningful change in foot function. To tackle these shortcomings, an advanced clinical examination platform integrating pressure-force-kinematic measurement devices was developed and showed its clinical value for the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has included this integrated use of three-dimensional multi-segment foot models, plantar pressure platform and a force platform to report on the functional outcome of an ankle arthrodesis or a total ankle replacement.

Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both centres are equipped with the same advanced clinical examination platform. It is believed that proposed approach has the potential to provide further insight in the true functional changes related to ankle arthrodesis and total ankle replacement. This may in turn result in improved rehabilitation, less risk for post-operative complications, earlier discharge and quicker resumption of normal activities of the daily living, which would make ankle arthrodesis and total ankle replacement more cost-efficient and could potentially affect thousands of patients each year. Therefore, the hypotheses of the present study are:

  • Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.
  • Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from ankle osteoarthritis.

Description

Inclusion Criteria:

  • primary osteoarthritis
  • post-traumatic osteoarthritis with an aligned or partially reducible deformity of the ankle and/or hindfoot

Exclusion Criteria:

  • history of orthopaedic lower limb surgery except for the ankle
  • neuromuscular disorders
  • vascular insufficiency
  • significant skin conditions such as skin ulcers or skin grafts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group, CG
For the purpose of the study, forty subjects for each group will be recruited. The control group (CG group) (so-called healthy subjects) CG will be recruited following the recruitment of the AA group and of the TAR group, as a sex, age and BMI matched design will be pursued. Inclusion criteria for the CG group are no history of orthopaedic lower limb surgery and absence of any known neurological or systematic disease.
Total ankle replacement group (TAR group)
The number of AA and TAR subjects used in a majority of studies to analyze the functional repercussion of an ankle arthrodesis or a total ankle replacement varied between 10 and 35 subjects.
Procedure: Total ankle replacement
A two-component ankle prosthesis will be inserted using the surgeon's standard technique, which essentially involves an anterior approach to the ankle joint. Once the joint is exposed, talar and tibial surfaces will be prepared and the prosthesis will be implanted according to the prosthesis surgical technique and its instrumentation.
Ankle arthrodesis group (AA group)
The number of AA and TAR subjects used in a majority of studies to analyze the functional repercussion of an ankle arthrodesis or a total ankle replacement varied between 10 and 35 subjects
Procedure: Ankle arthrodesis
Ankle arthrodesis consists of fusioning the joint surfaces of the ankle. The procedure will consist of removing the diseased cartilage and subchondral bone until bleeding of the cancellous bone surfaces is revealed. The bone ends will be opposed in the most appropriate and stable position and stabilized with screws or plates.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Foot and lower limb kinematics (degrees).
Time Frame: change from baseline (preoperative) to 12 months post-operatively
The Rizzoli 3D multi-segment foot model and the Rizzoli 3D lower limb model will be used to calculate changes pre-and post-operative foot and lower limb kinematics during barefoot walking.
change from baseline (preoperative) to 12 months post-operatively
Foot and lower limb kinematics (degrees).
Time Frame: change from baseline (preoperative) to 24 months post-operatively
The Rizzoli 3D multi-segment foot model and the Rizzoli 3D lower limb model will be used to calculate changes pre-and post-operative foot and lower limb kinematics during barefoot walking.
change from baseline (preoperative) to 24 months post-operatively
Joint moments (N.m/kg)
Time Frame: Change from baseline (preoperative) to 12 months post-operatively
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Change from baseline (preoperative) to 12 months post-operatively
Joint moments (N.m/kg)
Time Frame: Change from baseline (preoperative) to 24 months post-operatively
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Change from baseline (preoperative) to 24 months post-operatively
Force-time impulses (N.s)
Time Frame: Change from baseline (preoperative) to 12 months post-operatively
Force-time impulse is used to evaluate the effectiveness of a treatment at a specific foot location
Change from baseline (preoperative) to 12 months post-operatively
Force-time impulses (N.s)
Time Frame: Change from baseline (preoperative) to 24 months post-operatively
Force-time impulse is used to evaluate the effectiveness of a treatment at a specific foot location
Change from baseline (preoperative) to 24 months post-operatively
Power (W/kg)
Time Frame: Change from baseline (preoperative) to 24 months post-operatively
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Change from baseline (preoperative) to 24 months post-operatively
Power (W/kg)
Time Frame: Change from baseline (preoperative) to 12 months post-operatively
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Change from baseline (preoperative) to 12 months post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: pre-operatively
pre-operatively
Mechanical axis of the foot and lower limb (degrees)
Time Frame: pre-operatively
The medical records of participants who are eligible for the study, will be reviewed by a member of the research team to collect the standardized weightbearing anteroposterior ankle Meary view and standardized weightbearing lateral foot (and ankle) view to measure the mechanical axis of the foot and lower limb
pre-operatively
Position of the ankle arthrodesis or of the ankle prosthesis (degrees)
Time Frame: Change from baseline (preoperative) to 12 months post-operatively
The medical records of participants who are eligible for the study, will be reviewed by a member of the research team to collect the standardized weightbearing anteroposterior ankle Méary view and standardized weightbearing lateral foot (and ankle) view to measure the position of the ankle arthrodesis and/or of the ankle prosthesis.
Change from baseline (preoperative) to 12 months post-operatively
Health-related quality of life (SF-36)
Time Frame: Change from baseline (preoperative) to 12 months post-operatively
The Short-Form-36 (Version two) (SF-36) questionnaire will be used to assess health-related quality of life. The SF-36 is a 36 question survey that measures eight health concepts most affected by disease and treatment. The eight health concepts can then be used to form two summary measures: physical health and mental health. The SF-36 has been extensively validated and is one of the most widely used instruments to measure health status. The SF-36 has sound reliability and validity
Change from baseline (preoperative) to 12 months post-operatively
Health-related quality of life (SF-36)
Time Frame: Change from baseline (preoperative) to 24 months post-operatively
The Short-Form-36 (Version two) (SF-36) questionnaire will be used to assess health-related quality of life. The SF-36 is a 36 question survey that measures eight health concepts most affected by disease and treatment. The eight health concepts can then be used to form two summary measures: physical health and mental health. The SF-36 has been extensively validated and is one of the most widely used instruments to measure health status. The SF-36 has sound reliability and validity.
Change from baseline (preoperative) to 24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Luc BESSE, Dr, Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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