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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06029374
Other study ID # 1529/2023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date February 2026

Study information

Verified date August 2023
Source Medical University of Vienna
Contact Paul L Hoppe, M.D.
Phone 0043 1 40400 59160
Email paul.hoppe@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date February 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Functional Treatment
Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Other Visual Analogue Scale (VAS) Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain) at 0, 1, 2, 4 and 12 weeks
Other Strength Measurement dynamometer-based strength evaluation at 4 and 12 weeks
Other Range of Motion (ROM) Assessment goniometer-based ROM evaluation of hand and wrist at 4 and 12 weeks
Other Delayed Bone Healing number of participants with bone non-union at end of study at 12 weeks
Other Radiological Outcome x-ray based outcome of fracture healing in terms of axial deviation (measured in °) at 0, 1, 2, 4 and 12 weeks
Other Radiological Outcome x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm) at 0, 1, 2, 4 and 12 weeks
Other Quick DASH-Score patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function) at 0, 1, 2, 4 and 12 weeks
Other Brief Michigan-Hand-Outcome-Questionnaire patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) at 0, 1, 2 and 4 weeks
Other Occurrence of Complications occurence of complications due to treatment at 0, 1, 2, 4 and 12 weeks
Primary Brief Michigan-Hand-Outcome-Questionnaire patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) at 12 weeks
Secondary Loss/Gain of Reduction changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees) at 12 weeks
Secondary Treatment Failure Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition at 1, 2, 4 and 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06449755 - Elastic Nail Versus Screw for Intramedullary Fixation of Displaced Fractures of the Fifth Metacarpal Neck N/A
Recruiting NCT03607045 - Headless Screws x Bouquet in Boxer's Fracture N/A
Completed NCT01759758 - A Randomized Trial Comparing Conventional Plaster and Thermoplastic Splints to Treat Pediatric Boxer's Fractures N/A