Gait Analysis Following Total Ankle Replacement and Subtalar Fusion

NCT03356951 | Completed

• 1 other identifier: MAT
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Gait analysis

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

  1 day

Secondary Outcomes (3)

• VAS (Visual Analog Scale)

  1 day

• AOFAS

  1 day

• Short Form Health Survey (SF-12)

  1 day

Study Arms (2)

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

TAR through anterior approach and subtalar fusion PROCEDURE

Simultaneous total ankle replacement through anterior approach and subtalar fusion

Also known as: Hintegra ankle system

Anterior approach group

TAR through lateral approach and subtalar fusion PROCEDURE

Simultaneous total ankle replacement through lateral approach and subtalar fusion

Also known as: Zimmer TM (Trabecular Metal ) Total Ankle

Lateral approach group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent simoultanous total ankle replacement and subtalar fusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Orthopedic Hospital

Milan, 20161, Italy

Location

Related Publications (1)

• 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.

  PMID: 32381452 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: November 29, 2017
• Study Start: March 16, 2017
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: December 4, 2017

Record last verified: 2017-11

Locations

IT (1)