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

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ClinicalTrials.gov Identifier: NCT06022419
Recruitment Status : Not yet recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Paul L Hoppe, Medical University of Vienna

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 Outcome Measures:
  1. 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)

  2. Strength Measurement [ Time Frame: at 4 and 12 weeks ]
    dynamometer-based strength evaluation

  3. Range of Motion (ROM) Assessment [ Time Frame: at 4 and 12 weeks ]
    goniometer-based ROM evaluation of hand and wrist

  4. Delayed Bone Healing [ Time Frame: at 12 weeks ]
    number of participants with bone non-union at end of study

  5. 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 °)

  6. 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)

  7. 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)

  8. 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)

  9. Occurrence of Complications [ Time Frame: at 0, 1, 2, 4 and 12 weeks ]
    Occurrence of complications due to treatment


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022419


Contacts
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Contact: Paul L Hoppe, M.D. 0043 1 40400 59160 paul.hoppe@meduniwien.ac.at

Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Director: Gerhild Thalhammer, M.D. Medical University of Vienna
More Information
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Responsible Party: Paul L Hoppe, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT06022419    
Other Study ID Numbers: 1526/2023
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Calpastatin
Cysteine Proteinase Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action