Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting
LuCa
1 other identifier
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 1, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
June 15, 2025
June 1, 2025
3.8 years
August 26, 2023
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Brief Michigan-Hand-Outcome-Questionnaire
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
at 12 weeks
Secondary Outcomes (1)
Treatment Failure
at 1, 2, 4 and 12 weeks
Other Outcomes (9)
Visual Analogue Scale (VAS)
at 0, 1, 2, 4 and 12 weeks
Strength Measurement
at 4 and 12 weeks
Range of Motion (ROM) Assessment
at 4 and 12 weeks
- +6 more other outcomes
Study Arms (2)
Lucerne Cast
ACTIVE COMPARATORForearm Cast and Finger Splint
ACTIVE COMPARATORInterventions
Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.
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.
Eligibility Criteria
You may qualify if:
- Proximal phalanx fracture in the fingers (II - V)
- Patient age between 18 and 70 years
You may not qualify if:
- Condylar fracture
- Avulsions of the collateral ligament
- Pathologic fracture
- Intraarticular fracture
- Patients unable to consent
- Polytraumatized patients
- Patients initially presenting more than 7 days after injury
- Pregnancy
- Compound fractures
- Multiple hand injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna - Department of Orthopedics and Trauma-Surgery
Vienna, 1090, Austria
Study Officials
- STUDY DIRECTOR
Gerhild Thalhammer, M.D.
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 26, 2023
First Posted
September 1, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
June 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share