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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03356951
Enrollment
23
Registered
2017-11-29
Start date
2017-03-16
Completion date
2017-06-29
Last updated
2017-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Osteoarthritis

Brief summary

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.

Detailed description

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

Interventions

PROCEDURETAR through anterior approach and subtalar fusion

Simultaneous total ankle replacement through anterior approach and subtalar fusion

PROCEDURETAR through lateral approach and subtalar fusion

Simultaneous total ankle replacement through lateral approach and subtalar fusion

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gait analysis1 dayDifferences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs

Secondary

MeasureTime frameDescription
VAS (Visual Analog Scale)1 dayDifferences in Pain Scores on the Visual Analog Scale
AOFAS1 dayDifferences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score
Short Form Health Survey (SF-12)1 dayDifferences in Health Scores on the 12-Item Short Form Health Survey

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026