Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting (LuCa)
Primary Purpose
Proximal Phalanx Fracture
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lucerne Cast
Forearm Cast and Finger Splint
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Phalanx Fracture
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lucerne Cast
Forearm Cast and Finger Splint
Arm Description
Outcomes
Primary Outcome Measures
Brief Michigan-Hand-Outcome-Questionnaire
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Secondary Outcome Measures
Treatment Failure
Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition
Full Information
NCT ID
NCT06022419
First Posted
August 26, 2023
Last Updated
August 31, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT06022419
Brief Title
Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting
Acronym
LuCa
Official Title
Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Phalanx Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lucerne Cast
Arm Type
Active Comparator
Arm Title
Forearm Cast and Finger Splint
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lucerne Cast
Intervention Description
Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Forearm Cast and Finger Splint
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Michigan-Hand-Outcome-Questionnaire
Description
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Treatment Failure
Description
Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition
Time Frame
at 1, 2, 4 and 12 weeks
Other Pre-specified Outcome Measures:
Title
Visual Analogue Scale (VAS)
Description
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
Title
Strength Measurement
Description
dynamometer-based strength evaluation
Time Frame
at 4 and 12 weeks
Title
Range of Motion (ROM) Assessment
Description
goniometer-based ROM evaluation of hand and wrist
Time Frame
at 4 and 12 weeks
Title
Delayed Bone Healing
Description
number of participants with bone non-union at end of study
Time Frame
at 12 weeks
Title
Radiological Outcome
Description
x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
Time Frame
at 0, 1, 2, 4 and 12 weeks
Title
Radiological Outcome
Description
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
Title
Quick DASH-Score
Description
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
Title
Brief Michigan-Hand-Outcome-Questionnaire
Description
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Time Frame
at 0, 1, 2 and 4 weeks
Title
Occurrence of Complications
Description
Occurrence of complications due to treatment
Time Frame
at 0, 1, 2, 4 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul L Hoppe, M.D.
Phone
0043 1 40400 59160
Email
paul.hoppe@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhild Thalhammer, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting
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