Boxer's FractureBoxerFxNCT06029374
Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting
A study testing Functional Treatment and Forearm Cast and Finger Splint in people with Boxer's Fracture, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Boxer's Fracture
- What is being tested?
- Functional Treatment and Forearm Cast and Finger Splint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2023to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fifth Metacarpal Neck Fractures
- Patient age between 18 and 70 years
Who cannot join
- Palmar angulation >50° in first lateral x-ray
- Pathologic fracture
- Intraarticular fracture
- Patients unable to consent
- Polytraumatized patients
- Pregnancy
Show all 9Show fewer
- Compound fractures
- Multiple hand injuries
- Patients initially presenting more than 7 days after injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna - Department of Orthopedics and Trauma-Surgery
Vienna, 1090
Paul Hoppe, M.D., +4314040059160, paul.hoppe@meduniwien.ac.at
About this study
Official title: Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.
Read the detailed description
This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.
- Conditions
- Boxer's Fracture
- Being tested
- Functional Treatment, Forearm Cast and Finger Splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TreatmentProcedure or surgery
Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.
Forearm Cast and Finger SplintProcedure or surgery
Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional Treatment | Active comparator | Not described Receives: Procedure: Functional Treatment |
| Forearm Cast and Finger Splint | Active comparator | Not described Receives: Procedure: Forearm Cast and Finger Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Michigan-Hand-Outcome-Questionnaire
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Measured: at 12 weeks
Secondary outcomes (2)
Loss/Gain of Reduction
changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)
Measured: at 12 weeks
Treatment Failure
Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition
Measured: at 1, 2, 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Boxer's FractureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul L Hoppe, Medical University of Vienna
- Investigators
- Gerhild Thalhammer, M.D., Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029374
- Sponsor's protocol ID
- 1529/2023
- Acronym
- BoxerFx
- Status last verified
- Jun 2025
- First submitted
- 26 Aug 2023
- Last updated
- 18 Jun 2025
- Results posted
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
- ClinicalTrials.gov ID
- NCT06029374
- Acronym / sponsor ID
- BoxerFx / 1529/2023
- Conditions
- Boxer's Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 8 Sep 2023 (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.
The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.
Detailed description
This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Treatment | Active comparator | Procedure: Functional Treatment |
| Forearm Cast and Finger Splint | Active comparator | Procedure: Forearm Cast and Finger Splint |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fifth Metacarpal Neck Fractures
- Patient age between 18 and 70 years
Key exclusion criteria (9 listed)
- Palmar angulation >50° in first lateral x-ray
- Pathologic fracture
- Intraarticular fracture
- Patients unable to consent
- Polytraumatized patients
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 |
|---|---|---|
| Functional TreatmentPatients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks. | Procedure or surgery | Functional Treatment |
| Forearm Cast and Finger SplintPatients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks. | Procedure or surgery | Forearm Cast and Finger Splint |
Primary outcome
Brief Michigan-Hand-Outcome-Questionnaire
Time frame: at 12 weeks
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
2 secondary outcomes
Loss/Gain of Reduction
Time frame: at 12 weeks
Treatment Failure
Time frame: at 1, 2, 4 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- 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.
Gerhild Thalhammer, M.D. study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Treatment and Forearm Cast and Finger Splint in people with Boxer's Fracture, run by Medical University of Vienna at 1 site in Austria.
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 9 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul L Hoppe, M.D. (0043 1 40400 59160, paul.hoppe@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Michigan-Hand-Outcome-Questionnaire (time frame: at 12 weeks). 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 18 Jun 2025.