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Transitional Ankle Fracture Management Using a New Joystick Technique

Sponsor
The Fuzhou No 2 Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05012449
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
54
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the feasibility and short-term clinical efficacy of the arthrography-assisted joystick technique for the treatment of adolescent transitional ankle fracture.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Arthrography-assisted joystick technology.
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transitional Ankle Fracture Management Using a New Joystick Technique
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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 .

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic union [Through study completion, an average of 0.5 year.]

      The time of radiographic union

    Secondary Outcome Measures

    1. American Orthopedic Foot and Ankle Society (AOFAS) ankle score system. [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.

    Other Outcome Measures

    1. Measurement methods of the mechanical axis of lower limbs . [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shunyou Chen Fuzhou Fujian China 350007

    Sponsors and Collaborators

    • The Fuzhou No 2 Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shunyou Chen, Clinical Professor, The Fuzhou No 2 Hospital
    ClinicalTrials.gov Identifier:
    NCT05012449
    Other Study ID Numbers:
    • Shunyou
    First Posted:
    Aug 19, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shunyou Chen, Clinical Professor, The Fuzhou No 2 Hospital
    Arthrography, Joystick technique, Adolescent, Ankle fracture
    Additional relevant MeSH terms:
    Fractures, Bone
    Ankle Fractures
    Tibial Fractures

    Study Results

    No Results Posted as of Aug 19, 2021