Ankle OsteoarthritisAO-IFABNCT03157141
Ankle Osteoarthritis
An observational study of Ankle Osteoarthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- Ankle arthrodesis and Total ankle replacement
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jun 2020
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering from ankle osteoarthritis.
Who may be able to join
- primary osteoarthritis
- post-traumatic osteoarthritis with an aligned or partially reducible deformity of the ankle and/or hindfoot
Who cannot join
- history of orthopaedic lower limb surgery except for the ankle
- neuromuscular disorders
- vascular insufficiency
- significant skin conditions such as skin ulcers or skin grafts
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Jean-Luc BESSE, Dr, +33 4 78 86 28 28, jean-luc.besse@chu-lyon.fr
Laurence CHEZE, Prof., +33 4 72 44 80 98, laurence.cheze@univ-lyon1.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Ankle Osteoarthritis
- Being tested
- Ankle arthrodesis, Total ankle replacement
- Keywords
- Ankle osteoarthritis, total ankle replacement, ankle arthrodesis, kinematics, kinetics, plantar pressure measurements, functional compensatory adaptations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle arthrodesisProcedure or surgery
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.
Total ankle replacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Total ankle replacement | |
| 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 Receives: Procedure: Ankle arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and lower limb kinematics (degrees).
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.
Measured: change from baseline (preoperative) to 12 months post-operatively
Foot and lower limb kinematics (degrees).
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.
Measured: change from baseline (preoperative) to 24 months post-operatively
Joint moments (N.m/kg)
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Measured: Change from baseline (preoperative) to 12 months post-operatively
Joint moments (N.m/kg)
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Measured: Change from baseline (preoperative) to 24 months post-operatively
Force-time impulses (N.s)
Force-time impulse is used to evaluate the effectiveness of a treatment at a specific foot location
Measured: Change from baseline (preoperative) to 12 months post-operatively
Force-time impulses (N.s)
Force-time impulse is used to evaluate the effectiveness of a treatment at a specific foot location
Measured: Change from baseline (preoperative) to 24 months post-operatively
Power (W/kg)
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Measured: Change from baseline (preoperative) to 24 months post-operatively
Power (W/kg)
3D multisegment foot kinetic model will allow to quantify mechanical loading of intrinsic foot joints during barefoot walking.
Measured: Change from baseline (preoperative) to 12 months post-operatively
Secondary outcomes (5)
Demographic data
Measured: pre-operatively
Mechanical axis of the foot and lower limb (degrees)
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
Measured: pre-operatively
Position of the ankle arthrodesis or of the ankle prosthesis (degrees)
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.
Measured: Change from baseline (preoperative) to 12 months post-operatively
Health-related quality of life (SF-36)
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
Measured: Change from baseline (preoperative) to 12 months post-operatively
Health-related quality of life (SF-36)
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.
Measured: Change from baseline (preoperative) to 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJan 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc BESSE, Dr, Principal investigator, Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157141
- Sponsor's protocol ID
- 69HCL17_0223
- Acronym
- AO-IFAB
- Status last verified
- May 2017
- First submitted
- 27 Mar 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics
- ClinicalTrials.gov ID
- NCT03157141
- Acronym / sponsor ID
- AO-IFAB / 69HCL17_0223
- Conditions
- Ankle Osteoarthritis
- Keywords
- Ankle osteoarthritis, total ankle replacement, ankle arthrodesis, kinematics, kinetics, plantar pressure measurements, functional compensatory adaptations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 17 May 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Procedure: Total ankle replacementThe 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. |
| Ankle arthrodesis group (AA group) | – | Procedure: Ankle arthrodesisThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from ankle osteoarthritis.
Key inclusion criteria (2 listed)
- primary osteoarthritis
- post-traumatic osteoarthritis with an aligned or partially reducible deformity of the ankle and/or hindfoot
Key exclusion criteria (4 listed)
- history of orthopaedic lower limb surgery except for the ankle
- neuromuscular disorders
- vascular insufficiency
- significant skin conditions such as skin ulcers or skin grafts
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 |
|---|---|---|
| Ankle arthrodesisAnkle 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. | Procedure or surgery | Ankle arthrodesis group (AA group) |
| Total ankle replacementA 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. | Procedure or surgery | Total ankle replacement group (TAR group) |
Primary outcome
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.
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.
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.
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.
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
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
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.
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.
5 secondary outcomes
Demographic data
Time frame: pre-operatively
Mechanical axis of the foot and lower limb (degrees)
Time frame: pre-operatively
Position of the ankle arthrodesis or of the ankle prosthesis (degrees)
Time frame: 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
Health-related quality of life (SF-36)
Time frame: Change from baseline (preoperative) to 24 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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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.
Jean-Luc BESSE, Dr principal investigator
Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Osteoarthritis, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc BESSE, Dr (+33 4 78 86 28 28, jean-luc.besse@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and lower limb kinematics (degrees). (time frame: change from baseline (preoperative) to 12 months post-operatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017.