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

Sponsor

Medical University of Vienna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06022419

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proximal Phalanx Fracture	Procedure: Lucerne Cast Procedure: Forearm Cast and Finger Splint	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Visual Analogue Scale (VAS) [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 [at 4 and 12 weeks]
dynamometer-based strength evaluation
Range of Motion (ROM) Assessment [at 4 and 12 weeks]
goniometer-based ROM evaluation of hand and wrist
Delayed Bone Healing [at 12 weeks]
number of participants with bone non-union at end of study
Radiological Outcome [at 0, 1, 2, 4 and 12 weeks]
x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
Radiological Outcome [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 [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 [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 [at 0, 1, 2, 4 and 12 weeks]
Occurrence of complications due to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul L Hoppe, M.D., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT06022419

Other Study ID Numbers:

1526/2023

First Posted:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Calpastatin

Study Results

No Results Posted as of Sep 1, 2023