Tibial FractureTransitionalNCT05012449
Transitional Ankle Fracture Management Using a New Joystick Technique
A study testing Arthrography-assisted joystick technology. in people with Tibial Fracture, run by The Fuzhou No 2 Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Arthrography-assisted joystick technology.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Bilateral fracture.
- In association with epiphyseal dysplasia and neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the feasibility and short-term clinical efficacy of the arthrography-assisted joystick technique for the treatment of adolescent transitional ankle fracture.
Read the detailed description
Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.
- Conditions
- Tibial Fracture
- Being tested
- Arthrography-assisted joystick technology.
- Keywords
- Arthrography, Joystick technique, Adolescent, Ankle fracture
- Medical subject headings
- Tibial Fractures, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrography-assisted joystick technology.Procedure or surgery
Also called No arthrography-assisted joystick technology.
Arthrography-assisted joystick technology.
| Study group | Role | What they receive |
|---|---|---|
| Arthrography-assisted joystick technology. | Experimental | Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology. Receives: Procedure: Arthrography-assisted joystick technology. |
| No arthrography-assisted joystick technology. | No intervention | Adolescent transitional ankle fracture who were treated with open or close reduction . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic union
The time of radiographic union
Measured: Through study completion, an average of 0.5 year.
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 0.5 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Fuzhou No 2 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shunyou Chen, The Fuzhou No 2 Hospital
- Investigators
- Shunyou Chen, doctor, Study chair, The Fuzhou No 2 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012449
- Sponsor's protocol ID
- Shunyou
- Acronym
- Transitional
- Status last verified
- Jul 2021
- First submitted
- 30 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Ankle Fracture Management Using a New Joystick Technique
- ClinicalTrials.gov ID
- NCT05012449
- Acronym / sponsor ID
- Transitional / Shunyou
- Conditions
- Tibial Fracture
- Keywords
- Arthrography, Joystick technique, Adolescent, Ankle fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Fuzhou No 2 HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrography-assisted joystick technology. | Experimental | Procedure: Arthrography-assisted joystick technology.Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology. |
| No arthrography-assisted joystick technology. | No intervention | –Adolescent transitional ankle fracture who were treated with open or close reduction . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Bilateral fracture.
- In association with epiphyseal dysplasia and neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrography-assisted joystick technology.Also: No arthrography-assisted joystick technology.Arthrography-assisted joystick technology. | Procedure or surgery | Arthrography-assisted joystick technology. |
Primary outcome
Radiographic union
Time frame: Through study completion, an average of 0.5 year.
The time of radiographic union
1 secondary outcome
American Orthopedic Foot and Ankle Society (AOFAS) ankle score system.
Time frame: Through study completion, an average of 0.5 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunyou Chen, doctor study chair
The Fuzhou No 2 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrography-assisted joystick technology. in people with Tibial Fracture, run by The Fuzhou No 2 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic union (time frame: Through study completion, an average of 0.5 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.