Total Ankle Replacement: Clinical and Radiological Outcomes

NCT03650010 | Recruiting

• 1 other identifier: Tarus
• Study Type: observational
• Target: 1,066
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Arthritis

Outcome Measures

Primary Outcomes (6)

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

  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.

  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

• Changes in Short form 12 (SF 12)

  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.

  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

• Anterior distal tibial angle

  (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.

  Pre operatively

• Changes in beta angle

  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

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

• Changes in alpha angle

  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)

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

• Medial distal tibial angle

  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).

  Pre operatively

Secondary Outcomes (1)

• Changes in visual analogue scale

  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

Interventions

Total ankle replacement PROCEDURE

total ankle prosthesis through a lateral or an anterior approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1066 patients who underwent total ankle replacement

You may qualify if:

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

You may not qualify if:

• \- age \< 18 years at the time of surgery

Sponsors & Collaborators

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

Study Sites (1)

Irccs Istituto Ortopedico Galeazzi

Milan, Milano, 20156, Italy

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Ankle

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FEDERICO USUELLI, MD PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: August 28, 2018
• Study Start: May 11, 2016
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

IT (1)