Proximal Phalanx FractureLuCaNCT06022419
Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting
A study testing Lucerne Cast and Forearm Cast and Finger Splint in people with Proximal Phalanx 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 the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proximal Phalanx Fracture
- What is being tested?
- Lucerne Cast and Forearm Cast and Finger Splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 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
- Proximal phalanx fracture in the fingers (II - V)
- Patient age between 18 and 70 years
Who cannot join
- Condylar fracture
- Avulsions of the collateral ligament
- Pathologic fracture
- Intraarticular fracture
- Patients unable to consent
- Polytraumatized patients
Show all 10Show fewer
- Patients initially presenting more than 7 days after injury
- Pregnancy
- Compound fractures
- Multiple hand injuries
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 Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
The purpose of this prospective randomized controlled clinical trial is to evaluate if the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture.
Read the detailed description
This study represents a prospective randomized controlled clinical trial comparing two different conservative treatment options in patients with proximal phalanx fractures.
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, while patients in the study group will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks. Clinical outcome will be assessed 12 weeks after trauma.
- Conditions
- Proximal Phalanx Fracture
- Being tested
- Lucerne Cast, Forearm Cast and Finger Splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucerne CastProcedure or surgery
Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast 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 |
|---|---|---|
| Lucerne Cast | Active comparator | Not described Receives: Procedure: Lucerne Cast |
| 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 (1)
Treatment Failure
Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) 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 posted1 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 Proximal Phalanx 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
- 86 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
- NCT06022419
- Sponsor's protocol ID
- 1526/2023
- Acronym
- LuCa
- Status last verified
- Jun 2025
- First submitted
- 26 Aug 2023
- Last updated
- 15 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
- ClinicalTrials.gov ID
- NCT06022419
- Acronym / sponsor ID
- LuCa / 1526/2023
- Conditions
- Proximal Phalanx Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 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
- 1 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 the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture.
Detailed description
This study represents a prospective randomized controlled clinical trial comparing two different conservative treatment options in patients with proximal phalanx fractures.
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, while patients in the study group will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks. 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 |
|---|---|---|
| Lucerne Cast | Active comparator | Procedure: Lucerne Cast |
| 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)
- Proximal phalanx fracture in the fingers (II - V)
- Patient age between 18 and 70 years
Key exclusion criteria (10 listed)
- Condylar fracture
- Avulsions of the collateral ligament
- Pathologic fracture
- Intraarticular fracture
- Patients unable to consent
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 |
|---|---|---|
| Lucerne CastPatients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks. | Procedure or surgery | Lucerne Cast |
| 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)
1 secondary outcome
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 15 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Proximal Phalanx Fracture
Not yet recruiting
Lipofilling in Operative Hand Fracture Treatment
Adhesions, Hand Fractures
Recruiting
IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures
Hand; Fracture, Phalanx
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 Lucerne Cast and Forearm Cast and Finger Splint in people with Proximal Phalanx 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 10 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 15 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 15 Jun 2025.