Comparison of Customized and Standard Total Ankle Prostheses

December 21, 2023 updated by: Istituto Ortopedico Rizzoli

Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study

The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40126
        • Recruiting
        • Rizzoli Orthopaedic Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.
  • Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
  • Patients who have signed the "informed consent" approved by the Ethics Committee.

Exclusion Criteria:

  • Social conditions (homeless patients, with restrictions on personal freedom)
  • ASA 3 and 4
  • Deep venous insufficiency Lower limbs
  • History of Erisipelas lower limbs
  • Neurological or psychocognitive disorders
  • neurological diseases
  • Axial deformities of ankle >15°
  • Personal or family history of DVT or EP
  • Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
  • Pregnant women
  • Patients with rheumatic diseases
  • Patients that requires ancillary surgical procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional
In the STANDARD group, patients will undergo a primary TAR by implanting a prosthetic model of a standard design, that is the same for all using the usual surgical technique and instrumentation (based on the use of external leg guidance)
Procedure: Total ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Other Names:
  • Total ankle arthroplasty with anterior approach
Experimental: Custom
In the PERSONALIZED group, patients will undergo a primary TAR by implanting a prosthetic model with a design specifically based on each patient's actual ankle morphology and using PSI surgical technique and instrumentation.
Procedure: Total ankle arthroplasty
Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.
Other Names:
  • Total ankle arthroplasty with anterior approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle radiographic angles
Time Frame: at baseline (day 0)
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
at baseline (day 0)
Ankle radiographic angles
Time Frame: 3 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
3 months
Ankle radiographic angles
Time Frame: 6 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
6 months
Ankle radiographic angles
Time Frame: 12 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
12 months
Ankle radiographic angles
Time Frame: 18 months
Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short form 12
Time Frame: at baseline (day 0)
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
at baseline (day 0)
Short form 12
Time Frame: 3 months
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
3 months
Short form 12
Time Frame: 6 months
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
6 months
Short form 12
Time Frame: 12 months
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
12 months
Short form 12
Time Frame: 18 months
The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."
18 months
Visual Analogic Scale
Time Frame: at baseline (day 0)
Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
at baseline (day 0)
Visual Analogic Scale
Time Frame: 3 months
Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
3 months
Visual Analogic Scale
Time Frame: 6 months
Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
6 months
Visual Analogic Scale
Time Frame: 12 months
Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
12 months
Visual Analogic Scale
Time Frame: 18 months
Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.
18 months
American Orthopedic Foot and Ankle Score
Time Frame: at baseline (day 0)
This Score, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.
at baseline (day 0)
American Orthopedic Foot and Ankle Score
Time Frame: 3 months
The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.
3 months
American Orthopedic Foot and Ankle Score
Time Frame: 6 months
The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.
6 months
American Orthopedic Foot and Ankle Score
Time Frame: 12 months
The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.
12 months
American Orthopedic Foot and Ankle Score
Time Frame: 18 months
The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.
18 months
Ankle Range of motion
Time Frame: at baseline (day 0)
Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
at baseline (day 0)
Ankle Range of motion
Time Frame: 3 months
Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
3 months
Ankle Range of motion
Time Frame: 6 months
Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
6 months
Ankle Range of motion
Time Frame: 12 months
Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
12 months
Ankle Range of motion
Time Frame: 18 months
Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

September 26, 2024

Study Completion (Estimated)

July 26, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3POD-TAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Osteoarthritis

Clinical Trials on Total ankle arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe