Transitional Ankle Fracture Management Using a New Joystick Technique

Tibial Fracture Clinical Trial

— Transitional  

Official title:

Transitional Ankle Fracture Management Using a New Joystick Technique

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05012449
• Other study ID #: Shunyou
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2021
• Source: The Fuzhou No 2 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Tibial Fracture
• Tibial Fractures

Intervention

Procedure:
• Arthrography-assisted joystick technology.
Arthrography-assisted joystick technology.

Locations

Country	Name	City	State
China	Shunyou Chen	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The Fuzhou No 2 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement methods of the mechanical axis of lower limbs .	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.
Primary	Radiographic union	The time of radiographic union	Through study completion, an average of 0.5 year.
Secondary	American Orthopedic Foot and Ankle Society (AOFAS) ankle score system.	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.