Ankle Osteoarthritis

• Conditions: Ankle Osteoarthritis
• Interventions: Procedure: Total ankle replacement; Procedure: Ankle arthrodesis

• Registration Number: NCT03157141
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-03-27
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2019-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total ankle replacement group (TAR group)	Total ankle replacement	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 group (AA group)	Ankle arthrodesis	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

Primary Outcome Measures

Name	Time	Method
Force-time impulses (N.s)	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
Joint moments (N.m/kg)	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.
Foot and lower limb kinematics (degrees).	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.
Power (W/kg)	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.

Secondary Outcome Measures

Name	Time	Method
Demographic data	pre-operatively
Mechanical axis of the foot and lower limb (degrees)	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
Position of the ankle arthrodesis or of the ankle prosthesis (degrees)	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.
Health-related quality of life (SF-36)	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.

Trial Locations

Locations (1)

Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, France