Medical University of Vienna - Department of Orthopedics and Trauma-Surgery
Vienna, 1090, Austria
Location status: Recruiting
Recruiting
NCT Number: NCT06022419
Conservative Therapy of Proximal Phalanx Fractures - 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Proximal phalanx fracture in the fingers (II - V)
- Patient age between 18 and 70 years
Exclusion criteria
- 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
Treatment and study plan
Lucerne Cast
ProcedurePatients 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 Splint
ProcedurePatients 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.
Primary outcomes
-
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)
Secondary outcomes
-
Treatment Failure
Time frame: at 1, 2, 4 and 12 weeks
Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition
Other outcomes
-
Visual Analogue Scale (VAS)
Time frame: at 0, 1, 2, 4 and 12 weeks
Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)
-
Strength Measurement
Time frame: at 4 and 12 weeks
dynamometer-based strength evaluation
-
Range of Motion (ROM) Assessment
Time frame: at 4 and 12 weeks
goniometer-based ROM evaluation of hand and wrist
-
Delayed Bone Healing
Time frame: at 12 weeks
number of participants with bone non-union at end of study
-
Radiological Outcome
Time frame: at 0, 1, 2, 4 and 12 weeks
x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
-
Radiological Outcome
Time frame: at 0, 1, 2, 4 and 12 weeks
x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)
-
Quick DASH-Score
Time frame: at 0, 1, 2, 4 and 12 weeks
patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)
-
Brief Michigan-Hand-Outcome-Questionnaire
Time frame: at 0, 1, 2 and 4 weeks
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
-
Occurrence of Complications
Time frame: at 0, 1, 2, 4 and 12 weeks
Occurrence of complications due to treatment
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Medical University of Vienna
Other
Registry information
Official study title
Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
Acronym: LuCa
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Sep 1, 2023
- Registry last updated
- Jun 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.