Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Brief Michigan-Hand-Outcome-Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Lucerne Cast
Intervention: Lucerne Cast (Procedure)
Forearm Cast and Finger Splint
Intervention: Forearm Cast and Finger Splint (Procedure)
Outcomes
Primary Outcomes
Brief Michigan-Hand-Outcome-Questionnaire
Time Frame: at 12 weeks
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
Secondary Outcomes
- Treatment Failure(at 1, 2, 4 and 12 weeks)
Investigators
Paul L Hoppe
M.D.
Medical University of Vienna