An interventional study of Lucerne Cast and Forearm Cast and Finger Splint in Proximal Phalanx Fracture, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 86 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Lucerne Cast
Procedure: Forearm Cast and Finger Splint
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.
Brief Michigan-Hand-Outcome-Questionnaire
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Time frame: at 12 weeks
Treatment Failure
Occurrence of indication for surgery (malrotation, axial deviation \>10°, dorsal angulation \>20°) after primary reposition
Time frame: at 1, 2, 4 and 12 weeks
Visual Analogue Scale (VAS)
Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)
Time frame: at 0, 1, 2, 4 and 12 weeks
Strength Measurement
dynamometer-based strength evaluation
Time frame: at 4 and 12 weeks
Range of Motion (ROM) Assessment
goniometer-based ROM evaluation of hand and wrist
Time frame: at 4 and 12 weeks
Delayed Bone Healing
number of participants with bone non-union at end of study
Time frame: at 12 weeks
Radiological Outcome
x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
Time frame: at 0, 1, 2, 4 and 12 weeks
Radiological Outcome
x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)
Time frame: at 0, 1, 2, 4 and 12 weeks
Quick DASH-Score
patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)
Time frame: at 0, 1, 2, 4 and 12 weeks
Brief Michigan-Hand-Outcome-Questionnaire
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Time frame: at 0, 1, 2 and 4 weeks
Occurrence of Complications
Occurrence of complications due to treatment
Time frame: at 0, 1, 2, 4 and 12 weeks
Plan to share: No
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Medical University of Vienna