Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucerne Cast | Active Comparator |
| |
| Forearm Cast and Finger Splint | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucerne Cast | Procedure | Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Michigan-Hand-Outcome-Questionnaire | patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) after primary reposition | at 1, 2, 4 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Strength Measurement | dynamometer-based strength evaluation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul L Hoppe, M.D. | Contact | 0043 1 40400 59160 | paul.hoppe@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Gerhild Thalhammer, M.D. | Medical University of Vienna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna - Department of Orthopedics and Trauma-Surgery | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Forearm Cast and Finger Splint | Procedure | 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. |
|
| at 4 and 12 weeks |
| Range of Motion (ROM) Assessment | goniometer-based ROM evaluation of hand and wrist | at 4 and 12 weeks |
| Delayed Bone Healing | number of participants with bone non-union at end of study | at 12 weeks |
| Radiological Outcome | x-ray based outcome of fracture healing in terms of axial deviation (measured in °) | at 0, 1, 2, 4 and 12 weeks |
| 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 |
| 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 |
| 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 |
| Occurrence of Complications | Occurrence of complications due to treatment | at 0, 1, 2, 4 and 12 weeks |