CompletedNCT03356951Updated Dec 4, 2017

Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

An observational study in Ankle Osteoarthritis, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-04.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

Study type: Observational
Model: Case-control
Time perspective: Cross-sectional
Enrollment: 23
Ages: 20 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

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

Conditions studied

Ankle Osteoarthritis

In context

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

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Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients who underwent simoultanous total ankle replacement and subtalar fusion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Observational model: Case-control
Time perspective: Cross-sectional
Enrollment: 23 participants (actual)
Patient registry: No

Groups and cohorts

Lateral approach group
TAR through lateral approach and subtalar fusion
Procedure: TAR through lateral approach and subtalar fusion
Anterior approach group
TAR through anterior approach and subtalar fusion
Procedure: TAR through anterior approach and subtalar fusion

Interventions

ProcedureTAR through anterior approach and subtalar fusion
Simultaneous total ankle replacement through anterior approach and subtalar fusion
Also known as: Hintegra ankle system
ProcedureTAR through lateral approach and subtalar fusion
Simultaneous total ankle replacement through lateral approach and subtalar fusion
Also known as: Zimmer TM (Trabecular Metal ) Total Ankle

What researchers measure

Primary outcomes

Gait analysis
Differences in functional scores obtained by Mini-lab stereophotogrammetry-based Gait Analysis for Lower Limbs
Time frame: 1 day

Secondary outcomes

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

Study locations

1 site

IRCCS Galeazzi Orthopedic Hospital
Milan, 20161, Italy

References and documents

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. PubMed 32381452 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Jun 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 19, 2017
First posted: Nov 29, 2017
StartActual: Mar 16, 2017
Primary completionActual: Jun 29, 2017
CompletionActual: Jun 29, 2017
Last update: Dec 4, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03356951
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party: Sponsor
First posted: Nov 29, 2017
Start date: Mar 16, 2017
Primary completion: Jun 29, 2017
Completion: Jun 29, 2017
Last update: Dec 4, 2017

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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