Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2017-01-31
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis
NCT02025946
Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)
NCT07168330
Assessment of Preoperative and Postoperative Ankle Kinematics
NCT05868759
Total Ankle Replacement Versus Arthrodesis Trial
NCT02128555
Total Ankle Replacement: Clinical and Radiological Outcomes
NCT03650010
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* post-traumatic osteoarthritis with an aligned or partially reducible deformity of the ankle and/or hindfoot
Exclusion Criteria
* neuromuscular disorders
* vascular insufficiency
* significant skin conditions such as skin ulcers or skin grafts
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Luc BESSE, Dr
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL17_0223
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.