Mayo Wrist ScoreBFDNCT07884370
Treating Barton Fracture-Dislocation Combined With Soft Tissue Compromise
A study testing Fixation in people with Mayo Wrist Score, run by Xu Zhang at 1 site in China.
Trial summary
This study aimed to evaluate a minimally invasive treatment for Barton fracture-dislocation combined with soft tissue compromise. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mayo Wrist Score
- What is being tested?
- Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 30 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 65 years;
- closed injuries or minor skin injury;
- a diagnosis of BFDs established based on an intra-articular fracture;
- acute fractures within 21 days.
Who cannot join
- patients younger than 18 years because of skeleton immaturity;
- patients older than 65 years because they often tolerated some displacement;
- open fractures or 21 more days after injury;
- distal radius fractures other than BFDs;
- lack of opposite limb for comparison;
- uncooperative adults
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate a minimally invasive treatment for Barton fracture-dislocation combined with soft tissue compromise.
Read the detailed description
48 patients (48 limbs) who suffered from Barton fracture-dislocation combined with soft tissue injuries were treated. The mean age of the patients were 46 years (range, 34-64 years). The mean age of the patients was 46 years (range, 34-64 years). There were 22 male and 26 female patients. There were 35 volar and 13 dorsal Barton fracture-dislocations. There were types I (n=5), II (n=35), and III (n=8) based on the Mehara classification. The mean durations from injury to operation was 3 days (range, 1-17 days).
- Conditions
- Mayo Wrist Score
- Being tested
- Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FixationProcedure or surgery
surgical treatment of BFDs combined with soft tissue compromise
| Study group | Role | What they receive |
|---|---|---|
| external fixation | Other | distal radius fracture treated with surgery Receives: Procedure: Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Wrist Score
90-100, excellent; 80-90, good; 60-80, satisfactory; <60, poor
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start10 Jan 2020
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mayo Wrist ScoreStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Zhang, The Second Hospital of Qinhuangdao
- Investigators
- Xinzhong Shao, MD, Study chair, Third Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884370
- Sponsor's protocol ID
- W2024-119-1
- Acronym
- BFD
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Barton Fracture-Dislocation Combined With Soft Tissue Compromise
- ClinicalTrials.gov ID
- NCT07884370
- Acronym / sponsor ID
- BFD / W2024-119-1
- Conditions
- Mayo Wrist Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Xu ZhangUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 Oct 2026 (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.
This study aimed to evaluate a minimally invasive treatment for Barton fracture-dislocation combined with soft tissue compromise.
Detailed description
48 patients (48 limbs) who suffered from Barton fracture-dislocation combined with soft tissue injuries were treated. The mean age of the patients were 46 years (range, 34-64 years). The mean age of the patients was 46 years (range, 34-64 years). There were 22 male and 26 female patients. There were 35 volar and 13 dorsal Barton fracture-dislocations. There were types I (n=5), II (n=35), and III (n=8) based on the Mehara classification. The mean durations from injury to operation was 3 days (range, 1-17 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| external fixation | Other | Procedure: Fixationdistal radius fracture treated with surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 18 and 65 years;
- closed injuries or minor skin injury;
- a diagnosis of BFDs established based on an intra-articular fracture;
- acute fractures within 21 days.
Key exclusion criteria (6 listed)
- patients younger than 18 years because of skeleton immaturity;
- patients older than 65 years because they often tolerated some displacement;
- open fractures or 21 more days after injury;
- distal radius fractures other than BFDs;
- lack of opposite limb for comparison;
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 |
|---|---|---|
| Fixationsurgical treatment of BFDs combined with soft tissue compromise | Procedure or surgery | external fixation |
Primary outcome
Mayo Wrist Score
Time frame: up to 2 years
90-100, excellent; 80-90, good; 60-80, satisfactory; <60, poor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Xinzhong Shao, MD study chair
Third Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation in people with Mayo Wrist Score, run by Xu Zhang 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mayo Wrist Score (time frame: up to 2 years). 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 20 Oct 2026.