Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03650010

Total Ankle Replacement: Clinical and Radiological Outcomes

This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Istituto Ortopedico Galeazzi

Milan, Milano, 20156, Italy

Location status: Recruiting

Location contact

Federico Usuelli, MD

CONTACT

[email protected]

+39‭335 7351838‬

Federico Usuelli, MD

PRINCIPAL_INVESTIGATOR

About this study

The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics [1-4]. Therefore the data related to this study can be considered a reference in the literature.

Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.

The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females
  • age ≥ 18 years at the time of surgery
  • patients who underwent ankle replacement surgery from January 2011 to March 2026

Exclusion criteria

  • age < 18 years at the time of surgery

Treatment and study plan

Total ankle replacement

Procedure

total ankle prosthesis through a lateral or an anterior approach

Primary outcomes

  1. Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score

    Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

    The American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). Pain consists of one item with a maximal score of 40 points, indicating no pain. Function consists of seven items with a maximal score of 50 points, indicating full function. Alignment consists of one item with a maximal score of 10 points, indicating good alignment. The maximal score is 100 points, indicating no symptoms or impairments.

  2. Changes in Short form 12 (SF 12)

    Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

    The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  3. Anterior distal tibial angle

    Time frame: Pre operatively

    (ADTA: normal value 83.0 ± 3.6 degrees). The angle is subtended by the anatomic axis of the tibia and the line connecting the distal points on the anterior and posterior tibial articular surface on the anterior side (Figure 1). The tibia axis was defined as the line connecting the centres of two circles designed over the proximal and the distal tibia adjusting their radius to the anterior and posterior tibial cortices.

  4. Changes in beta angle

    Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

    β-angle (normal value 85.0 ± 2.0 degrees). This angle is subtended anteriorly by the longitudinal axis of the tibia and the articular surface of the tibial component on the lateral view

  5. Changes in alpha angle

    Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

    the α-angle is formed by the angle between the anatomic axis of the tibia and the articular surface of the tibial component on the AP view (normal value 90.0 ± 2.0 degrees)

  6. Medial distal tibial angle

    Time frame: Pre operatively

    It is the angle between the anatomic axis of the tibia and the line connecting the distal point on the medial and lateral articular surface. (normal value 92.4 ± 3.1 degrees).

Secondary outcomes

  1. Changes in visual analogue scale

    Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively

    The visual analogue scale or visual analog scale (VAS) is a psychometric response scale. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2018
Registry last updated
Aug 28, 2018

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.

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