Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting (LuCa)

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Phalanx Fracture
• Intervention / Treatment: Procedure: Lucerne Cast; Procedure: Forearm Cast and Finger Splint

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 Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul L Hoppe, M.D.; Phone Number: 0043 1 40400 59160; Email: paul.hoppe@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna - Department of Orthopedics and Trauma-Surgery
    • Contact: Paul Hoppe, M.D.; Phone Number: +4314040059160; Email: paul.hoppe@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lucerne Cast	Procedure: Lucerne Cast; Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.
Active Comparator: Forearm Cast and Finger Splint	Procedure: Forearm Cast and Finger Splint; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Michigan-Hand-Outcome-Questionnaire	patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Failure	Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition	at 1, 2, 4 and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)	at 0, 1, 2, 4 and 12 weeks
Strength Measurement	dynamometer-based strength evaluation	at 4 and 12 weeks
Range of Motion (ROM) Assessment	goniometer-based ROM evaluation of hand and wrist	at 4 and 12 weeks
Delayed Bone Healing	number of participants with bone non-union at end of study	at 12 weeks
Radiological Outcome	x-ray based outcome of fracture healing in terms of axial deviation (measured in °)	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)	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)	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)	at 0, 1, 2 and 4 weeks
Occurrence of Complications	Occurrence of complications due to treatment	at 0, 1, 2, 4 and 12 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Director: Gerhild Thalhammer, M.D., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 1526/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No