Back to resultsTransitional Ankle Fracture Management Using a New Joystick Technique (Transitional)
Primary Purpose
Tibial Fracture
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arthrography-assisted joystick technology.
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fracture focused on measuring Arthrography, Joystick technique, Adolescent, Ankle fracture
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Bilateral fracture.
- In association with epiphyseal dysplasia and neuromuscular disease.
Sites / Locations
- Shunyou Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arthrography-assisted joystick technology.
No arthrography-assisted joystick technology.
Arm Description
Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.
Adolescent transitional ankle fracture who were treated with open or close reduction .
Outcomes
Primary Outcome Measures
Radiographic union
The time of radiographic union
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05012449
First Posted
July 30, 2021
Last Updated
August 12, 2021
Sponsor
The Fuzhou No 2 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05012449
Brief Title
Transitional Ankle Fracture Management Using a New Joystick Technique
Acronym
Transitional
Official Title
Transitional Ankle Fracture Management Using a New Joystick Technique
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Fuzhou No 2 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
Keywords
Arthrography, Joystick technique, Adolescent, Ankle fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthrography-assisted joystick technology.
Arm Type
Experimental
Arm Description
Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.
Arm Title
No arthrography-assisted joystick technology.
Arm Type
No Intervention
Arm Description
Adolescent transitional ankle fracture who were treated with open or close reduction .
Intervention Type
Procedure
Intervention Name(s)
Arthrography-assisted joystick technology.
Other Intervention Name(s)
No arthrography-assisted joystick technology.
Intervention Description
Arthrography-assisted joystick technology.
Primary Outcome Measure Information:
Title
Radiographic union
Description
The time of radiographic union
Time Frame
Through study completion, an average of 0.5 year.
Secondary Outcome Measure Information:
Title
American Orthopedic Foot and Ankle Society (AOFAS) ankle score system.
Description
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.
Time Frame
Through study completion, an average of 0.5 year.
Other Pre-specified Outcome Measures:
Title
Measurement methods of the mechanical axis of lower limbs .
Description
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.
Time Frame
Through study completion, an average of 0.5 year.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Bilateral fracture.
In association with epiphyseal dysplasia and neuromuscular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunyou Chen, doctor
Organizational Affiliation
The Fuzhou No 2 Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shunyou Chen
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350007
Country
China
12. IPD Sharing Statement
Learn more about this trial
Transitional Ankle Fracture Management Using a New Joystick Technique
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