Ankle Osteoarthritis

Ankle Osteoarthritis Clinical Trial

— AO-IFAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157141
• Other study ID #: 69HCL17_0223
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2017
• Last updated: May 16, 2017
• Start date: January 2017
• Est. completion date: June 2020

Study information

• Verified date: May 2017
• Source: Hospices Civils de Lyon
• Contact: Jean-Luc BESSE, Dr
• Phone: +33 4 78 86 28 28
• Email: jean-luc.besse[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline (preoperative) to 12 months post-operatively
Primary	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.	change from baseline (preoperative) to 24 months post-operatively
Primary	Joint moments (N.m/kg)	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
Primary	Joint moments (N.m/kg)	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
Primary	Force-time impulses (N.s)	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
Primary	Force-time impulses (N.s)	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
Primary	Power (W/kg)	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
Primary	Power (W/kg)	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	Demographic data		pre-operatively
Secondary	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	pre-operatively
Secondary	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.	Change from baseline (preoperative) to 12 months post-operatively
Secondary	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	Change from baseline (preoperative) to 12 months post-operatively
Secondary	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.	Change from baseline (preoperative) to 24 months post-operatively