Transitional Ankle Fracture Management Using a New Joystick Technique (Transitional)

August 12, 2021 updated by: Shunyou Chen, The Fuzhou No 2 Hospital
To investigate the feasibility and short-term clinical efficacy of the arthrography-assisted joystick technique for the treatment of adolescent transitional ankle fracture.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350007
        • Shunyou Chen

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. X-ray or computed tomography (CT) diagnosis of adolescent transitional ankle fracture.
  2. After manual reduction, the displacement of both ends of the epiphyseal plate or articular surface fracture in any direction was still > 2 mm; the arthrography-assisted joystick technique was used for treatment.

Exclusion Criteria:

  1. Bilateral fracture.
  2. In association with epiphyseal dysplasia and neuromuscular disease.

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arthrography-assisted joystick technology.
Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.
Procedure: Arthrography-assisted joystick technology.
Arthrography-assisted joystick technology.
Other Names:
  • No arthrography-assisted joystick technology.
No Intervention: No arthrography-assisted joystick technology.
Adolescent transitional ankle fracture who were treated with open or close reduction .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic union
Time Frame: Through study completion, an average of 0.5 year.
The time of radiographic union
Through study completion, an average of 0.5 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Orthopedic Foot and Ankle Society (AOFAS) ankle score system.
Time Frame: Through study completion, an average of 0.5 year.
The AOFAS evaluation criteria were used to evaluate ankle function and healing: 90-100 points = an excellent outcome; 75-89 points = a good outcome; 50-74 points = a fair outcome; and < 50 points = a poor outcome. The scoring criteria include pain, functional and autonomic activity, support, maximum walking distance, ground walking, abnormal gait, forefoot activity, hindfoot activity, ankle-hindfoot stability, and foot alignment.
Through study completion, an average of 0.5 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement methods of the mechanical axis of lower limbs .
Time Frame: Through study completion, an average of 0.5 year.
Quantitative indicators included the full length of the tibia, the angle formed by the mechanical axis of the lower limbs in standing position and the horizontal line, and the angle of ankle mortise in coronal and sagittal positions.
Through study completion, an average of 0.5 year.

Collaborators and Investigators

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

Sponsor

The Fuzhou No 2 Hospital

Investigators

  • Study Chair: Shunyou Chen, doctor, The Fuzhou No 2 Hospital

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 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shunyou

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.

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