Clinical trial NCT03157141: Ankle Osteoarthritis
Official title: Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Osteoarthritis
Keywords: Ankle osteoarthritis
total ankle replacement
ankle arthrodesis
kinematics
kinetics
plantar pressure measurements
functional compensatory adaptations
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from ankle osteoarthritis.

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Foot and lower limb kinematics (degrees).
timeFrame: change from baseline (preoperative) to 12 months post-operatively
measure: Foot and lower limb kinematics (degrees).
timeFrame: change from baseline (preoperative) to 24 months post-operatively
measure: Joint moments (N.m/kg)
timeFrame: Change from baseline (preoperative) to 12 months post-operatively
measure: Joint moments (N.m/kg)
timeFrame: Change from baseline (preoperative) to 24 months post-operatively
measure: Force-time impulses (N.s)
timeFrame: Change from baseline (preoperative) to 12 months post-operatively
measure: Force-time impulses (N.s)
timeFrame: Change from baseline (preoperative) to 24 months post-operatively
measure: Power (W/kg)
timeFrame: Change from baseline (preoperative) to 24 months post-operatively
measure: Power (W/kg)
timeFrame: Change from baseline (preoperative) to 12 months post-operatively
Secondary outcomes:
measure: Demographic data
timeFrame: pre-operatively
measure: Mechanical axis of the foot and lower limb (degrees)
timeFrame: pre-operatively
measure: Position of the ankle arthrodesis or of the ankle prosthesis (degrees)
timeFrame: Change from baseline (preoperative) to 12 months post-operatively
measure: Health-related quality of life (SF-36)
timeFrame: Change from baseline (preoperative) to 12 months post-operatively
measure: Health-related quality of life (SF-36)
timeFrame: Change from baseline (preoperative) to 24 months post-operatively
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon-Sud
Study officials:
affiliation: Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France
name: Jean-Luc BESSE, Dr
role: PRINCIPAL_INVESTIGATOR
References: