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

Not Applicable

Not yet recruiting

• Conditions: Proximal Phalanx Fracture
• Interventions: Procedure: Lucerne Cast; Procedure: Forearm Cast and Finger Splint

• Registration Number: NCT06022419
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study Start: 2023-09
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lucerne Cast	Lucerne Cast	-
Forearm Cast and Finger Splint	Forearm Cast and Finger Splint	-

Primary Outcome Measures

Name	Time	Method
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

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