Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation

Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle replacement and subtalar fusion. With the development of new prosthetic designs and of surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion with functional and quality of life improvements. A gait analysis of patients that underwent TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the subtalar joint in such a way that it is not possible to analyze the two joints separately. Also, excluding the role of the subtalar joint, it is possible to accurately analyze and compare the consequences on ankle kinematics of two different prosthetic designs.

Study Overview

• Status: Completed
• Conditions: Ankle Osteoarthritis
• Intervention / Treatment: Procedure: TAR through lateral approach and subtalar fusion; Procedure: TAR through anterior approach and subtalar fusion

Detailed Description

Patients who previously have underwent TAR and simultaneous subtalar fusion are retrospectively reviewed. Minimum follow-up after the surgery is 12 months.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20161
    • IRCCS Galeazzi Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent simoultanous total ankle replacement and subtalar fusion

Description

Inclusion Criteria:

• Patients who underwent ankle prosthesis (Hintegra ankle system, Zimmer Trabecular Metal Total Ankle) and simultaneous fusion of the subtalar joint with at least 12 months of follow-up willing and capable of adhering to postoperative clinical protocols and functional evaluations and who have signed a specific informed consent form approved by the Ethics Committee
• Males or females aged between 20 and 80 years old.
• Patients with diagnosis of primary not-inflammatory degenerative articular disease

Exclusion Criteria:

• Patients with Body Mass Index (BMI)> 35.
• Patients with active or suspected latent periprosthetic infection
• Patients who underwent revision surgery.
• Prosthesis of the hip, knee or ankle, homolateral or contralateral.
• Fusion failure of subtalar joint.
• Patients with chronic heart failure (NYHA stage> 2)
• Presence of neurological disorders, neuromuscular disorders or other major musculoskeletal pathologies
• Cognitive deficits.
• Impossibility to match questionnaires due to cognitive disorders or language dysfunctional disorders

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lateral approach group; TAR through lateral approach and subtalar fusion	Procedure: TAR through lateral approach and subtalar fusion; Simultaneous total ankle replacement through lateral approach and subtalar fusion; Other Names: Zimmer TM (Trabecular Metal ) Total Ankle
Anterior approach group; TAR through anterior approach and subtalar fusion	Procedure: TAR through anterior approach and subtalar fusion; Simultaneous total ankle replacement through anterior approach and subtalar fusion; Other Names: Hintegra ankle system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis	Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual Analog Scale)	Differences in Pain Scores on the Visual Analog Scale	1 day
AOFAS	Differences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score	1 day
Short Form Health Survey (SF-12)	Differences in Health Scores on the 12-Item Short Form Health Survey	1 day

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Publications and helpful links

General Publications

• Usuelli FG, Indino C, Leardini A, Manzi L, Ortolani M, Caravaggi P. Range of motion of foot joints following total ankle replacement and subtalar fusion. Foot Ankle Surg. 2021 Feb;27(2):150-155. doi: 10.1016/j.fas.2020.03.015. Epub 2020 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: MAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No