Clinical trial NCT03356951: Gait Analysis Following Total Ankle Replacement and Subtalar Fusion
Official title: Analysis of Patients Who Underwent Ankle Replacement and Simultaneous Subtalar Fusion by Biomechanical and Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Osteoarthritis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent simoultanous total ankle replacement and subtalar fusion

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait analysis
timeFrame: 1 day
Secondary outcomes:
measure: VAS (Visual Analog Scale)
timeFrame: 1 day
measure: AOFAS
timeFrame: 1 day
measure: Short Form Health Survey (SF-12)
timeFrame: 1 day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Hospital
Study officials:
References:
citation: 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.