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Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

NCT ID: NCT03356951

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-16

Study Completion Date

2017-06-29

Brief Summary

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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

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

Conditions

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Ankle Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lateral approach group

TAR through lateral approach and subtalar fusion

TAR through lateral approach and subtalar fusion

Intervention Type PROCEDURE

Simultaneous total ankle replacement through lateral approach and subtalar fusion

Anterior approach group

TAR through anterior approach and subtalar fusion

TAR through anterior approach and subtalar fusion

Intervention Type PROCEDURE

Simultaneous total ankle replacement through anterior approach and subtalar fusion

Interventions

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TAR through anterior approach and subtalar fusion

Simultaneous total ankle replacement through anterior approach and subtalar fusion

Intervention Type PROCEDURE

TAR through lateral approach and subtalar fusion

Simultaneous total ankle replacement through lateral approach and subtalar fusion

Intervention Type PROCEDURE

Other Intervention Names

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Hintegra ankle system Zimmer TM (Trabecular Metal ) Total Ankle

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Galeazzi Orthopedic Hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 32381452 (View on PubMed)

Other Identifiers

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MAT

Identifier Type: -

Identifier Source: org_study_id