Proximal Phalanx Fracture
Conditions
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.
Interventions
PROCEDURELucerne Cast
Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.
PROCEDUREForearm 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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Michigan-Hand-Outcome-Questionnaire | at 12 weeks | patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | at 1, 2, 4 and 12 weeks | Occurrence of indication for surgery (malrotation, axial deviation \>10°, dorsal angulation \>20°) after primary reposition |
Other
| Measure | Time frame | Description |
|---|---|---|
| Strength Measurement | at 4 and 12 weeks | dynamometer-based strength evaluation |
| Range of Motion (ROM) Assessment | at 4 and 12 weeks | goniometer-based ROM evaluation of hand and wrist |
| Delayed Bone Healing | at 12 weeks | number of participants with bone non-union at end of study |
| Radiological Outcome | at 0, 1, 2, 4 and 12 weeks | x-ray based outcome of fracture healing in terms of axial deviation (measured in °) |
| Quick DASH-Score | at 0, 1, 2, 4 and 12 weeks | patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function) |
| Brief Michigan-Hand-Outcome-Questionnaire | at 0, 1, 2 and 4 weeks | patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) |
| Occurrence of Complications | at 0, 1, 2, 4 and 12 weeks | Occurrence of complications due to treatment |
| Visual Analogue Scale (VAS) | at 0, 1, 2, 4 and 12 weeks | Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain) |
Countries
Austria
Contacts
Primary ContactPaul L Hoppe, M.D.
Outcome results
None listed