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

Medical University of Vienna

Status: Enrolling

Conditions: Proximal Phalanx Fracture

Treatments: Procedure: Lucerne Cast; Procedure: Forearm Cast and Finger Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT06022419

1526/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Lucerne Cast

Active Comparator group

Treatment:

Procedure: Lucerne Cast

Forearm Cast and Finger Splint

Active Comparator group

Treatment:

Procedure: Forearm Cast and Finger Splint