NCT05012449

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 19, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

July 30, 2021

Last Update Submit

August 12, 2021

Conditions

Tibial Fracture

Keywords

Arthrography, Joystick technique, Adolescent, Ankle fracture

Outcome Measures

Primary Outcomes (1)

  • Radiographic union

    The time of radiographic union

    Through study completion, an average of 0.5 year.

Secondary Outcomes (1)

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

    Through study completion, an average of 0.5 year.

Other Outcomes (1)

  • Measurement methods of the mechanical axis of lower limbs .

    Through study completion, an average of 0.5 year.

Study Arms (2)

Arthrography-assisted joystick technology.

EXPERIMENTAL

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

Procedure: Arthrography-assisted joystick technology.

No arthrography-assisted joystick technology.

NO INTERVENTION

Adolescent transitional ankle fracture who were treated with open or close reduction .

Interventions

Arthrography-assisted joystick technology.PROCEDURE

Arthrography-assisted joystick technology.

Also known as: No arthrography-assisted joystick technology.
Arthrography-assisted joystick technology.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • X-ray or computed tomography (CT) diagnosis of adolescent transitional ankle fracture.
  • 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.

You may not qualify if:

  • Bilateral fracture.
  • In association with epiphyseal dysplasia and neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shunyou Chen

Fuzhou, Fujian, 350007, China

Location

MeSH Terms

Conditions

Tibial FracturesAnkle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesAnkle Injuries

Study Officials

  • Shunyou Chen, doctor

    The Fuzhou No 2 Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 19, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

December 31, 2025

Last Updated

August 19, 2021

Record last verified: 2021-07

Locations

CN(1)