Ankle Osteoarthritis

NCT03157141 | Unknown

• 1 other identifier: 69HCL17_0223
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Keywords

Ankle osteoarthritis; total ankle replacement; ankle arthrodesis; kinematics; kinetics; plantar pressure measurements; functional compensatory adaptations

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Demographic data

  pre-operatively

• Mechanical axis of the foot and lower limb (degrees)

  pre-operatively

• Position of the ankle arthrodesis or of the ankle prosthesis (degrees)

  Change from baseline (preoperative) to 12 months post-operatively

• Health-related quality of life (SF-36)

  Change from baseline (preoperative) to 12 months post-operatively

• Health-related quality of life (SF-36)

  Change from baseline (preoperative) to 24 months post-operatively

Study Arms (3)

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.

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

Procedure: Ankle arthrodesis

Interventions

Ankle arthrodesis PROCEDURE

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.

Ankle arthrodesis group (AA group)

Total ankle replacement PROCEDURE

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.

Total ankle replacement group (TAR group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from ankle osteoarthritis.

You may qualify if:

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

You may not qualify if:

• history of orthopaedic lower limb surgery except for the ankle
• neuromuscular disorders
• vascular insufficiency
• significant skin conditions such as skin ulcers or skin grafts

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Ankle

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jean-Luc BESSE, Dr

  Centre Hospitalier Lyon-Sud, 69495 Pierre-Bénite Cédex, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc BESSE, Dr

CONTACT

+33 4 78 86 28 28; jean-luc.besse@chu-lyon.fr

Laurence CHEZE, Prof.

CONTACT

+33 4 72 44 80 98; laurence.cheze@univ-lyon1.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 17, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

FR (1)