Skip to main content
OpenTrials
Completed

NCT Number: NCT03356951

Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankle Osteoarthritis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAR through anterior approach and subtalar fusion

Procedure

Simultaneous total ankle replacement through anterior approach and subtalar fusion

Other names: Hintegra ankle system

TAR through lateral approach and subtalar fusion

Procedure

Simultaneous total ankle replacement through lateral approach and subtalar fusion

Other names: Zimmer TM (Trabecular Metal ) Total Ankle

Primary outcomes

  1. Gait analysis

    Time frame: 1 day

    Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs

Secondary outcomes

  1. VAS (Visual Analog Scale)

    Time frame: 1 day

    Differences in Pain Scores on the Visual Analog Scale

  2. AOFAS

    Time frame: 1 day

    Differences in Functional Scores on the American Orthopaedic Foot and Ankle Society Score

  3. Short Form Health Survey (SF-12)

    Time frame: 1 day

    Differences in Health Scores on the 12-Item Short Form Health Survey

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2017
Registry last updated
Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.