Transitional Ankle Fracture Management Using a New Joystick Technique

Not Applicable

Active, not recruiting

• Conditions: Tibial Fracture
• Interventions: Procedure: Arthrography-assisted joystick technology.

• Registration Number: NCT05012449
• Lead Sponsor: The Fuzhou No 2 Hospital

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.

Detailed Description

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

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19
• Primary Completion: 2023-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arthrography-assisted joystick technology.	Arthrography-assisted joystick technology.	Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.

Primary Outcome Measures

Name	Time	Method
Radiographic union	Through study completion, an average of 0.5 year.	The time of radiographic union

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shunyou Chen; 🇨🇳 Fuzhou, Fujian, China