Clinical trial NCT06029374: Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting
Official title: Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Boxer's Fracture
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 100
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 functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.

Detailed description: This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.

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 in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.

Eligibility criteria: Inclusion Criteria:

* Fifth Metacarpal Neck Fractures
* Patient age between 18 and 70 years

Exclusion Criteria:

* Palmar angulation \>50° in first lateral x-ray
* Pathologic fracture
* Intraarticular fracture
* Patients unable to consent
* Polytraumatized patients
* Pregnancy
* Compound fractures
* Multiple hand injuries
* Patients initially presenting more than 7 days after injury

Primary outcomes:
measure: Brief Michigan-Hand-Outcome-Questionnaire
timeFrame: at 12 weeks
Secondary outcomes:
measure: Loss/Gain of Reduction
timeFrame: at 12 weeks
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: