Clinical trial NCT06022419: Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting
Official title: Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Phalanx Fracture
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Brief Michigan-Hand-Outcome-Questionnaire
timeFrame: at 12 weeks
Secondary outcomes:
measure: Treatment Failure
timeFrame: at 1, 2, 4 and 12 weeks
Other outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: at 0, 1, 2, 4 and 12 weeks
measure: Strength Measurement
timeFrame: at 4 and 12 weeks
measure: Range of Motion (ROM) Assessment
timeFrame: at 4 and 12 weeks
measure: Delayed Bone Healing
timeFrame: at 12 weeks
measure: Radiological Outcome
timeFrame: at 0, 1, 2, 4 and 12 weeks
measure: Radiological Outcome
timeFrame: at 0, 1, 2, 4 and 12 weeks
measure: Quick DASH-Score
timeFrame: at 0, 1, 2, 4 and 12 weeks
measure: Brief Michigan-Hand-Outcome-Questionnaire
timeFrame: at 0, 1, 2 and 4 weeks
measure: Occurrence of Complications
timeFrame: at 0, 1, 2, 4 and 12 weeks
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Department of Orthopedics and Trauma-Surgery
Study officials:
affiliation: Medical University of Vienna
name: Gerhild Thalhammer, M.D.
role: STUDY_DIRECTOR
References: