Back to resultsBuddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
Primary Purpose
Fracture Finger
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
fracture immobilization after reduction of displaced finger fractures
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Finger
Eligibility Criteria
Inclusion Criteria:
- extraarticular displaced finger fractures of the proximal or middle phalanges
Exclusion Criteria:
- fractures of the thumb
- fractures that are open, instable, pathologic or multifragmented
- multiple fractures of the Hand
- phalangeal neck fractures
- presentation later than 5 days after the injury
Sites / Locations
- University Children's Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buddy taping
splint immobilization
Arm Description
Buddy taping of the fractured finger to ist neighbouring uninjured finger.
A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb.
Outcomes
Primary Outcome Measures
secondary fracture displacement
X-ray controls
Secondary Outcome Measures
Patient comfort
visual analog scale (VAS): Smiley scale with a range from 1 to 10, 10 being the highest score possible, indicating that the Patient comfort was very high.
Need for analgesic medication
interview with Patient and parents
total range of Motion
measurement
Full Information
NCT ID
NCT04068935
First Posted
August 23, 2019
Last Updated
May 15, 2023
Sponsor
University Children's Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04068935
Brief Title
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
Official Title
Buddy Taping Compared to Splint Immobilizations for Reduced Paediatric Finger Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fracture immobilization with Buddy taping is not inferior to Splint immobilization for non-displaced extra-articular paediatric finger fractures. However, whether the same applies for reduced finger fractures is unclear.
Detailed Description
Displaced fractures will be reduced in the paediatric ED by Emergency physicians. After fracture reduction, fracture immobilization will either be done with a Splint immobilization or a fingertaping. After 4 and 21 days, clinical and radiographic controls will take place at the Hand surgery outpatient clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buddy taping
Arm Type
Experimental
Arm Description
Buddy taping of the fractured finger to ist neighbouring uninjured finger.
Arm Title
splint immobilization
Arm Type
Active Comparator
Arm Description
A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb.
Intervention Type
Procedure
Intervention Name(s)
fracture immobilization after reduction of displaced finger fractures
Intervention Description
After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization
Primary Outcome Measure Information:
Title
secondary fracture displacement
Description
X-ray controls
Time Frame
5 and 21 days after fracture reduction
Secondary Outcome Measure Information:
Title
Patient comfort
Description
visual analog scale (VAS): Smiley scale with a range from 1 to 10, 10 being the highest score possible, indicating that the Patient comfort was very high.
Time Frame
5 and 21 days after fracture reduction
Title
Need for analgesic medication
Description
interview with Patient and parents
Time Frame
5 and 21 days after fracture reduction
Title
total range of Motion
Description
measurement
Time Frame
6 month after fracture reduction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
extraarticular displaced finger fractures of the proximal or middle phalanges
Exclusion Criteria:
fractures of the thumb
fractures that are open, instable, pathologic or multifragmented
multiple fractures of the Hand
phalangeal neck fractures
presentation later than 5 days after the injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Seiler, MD
Organizational Affiliation
University Children's Hospital, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Zurich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
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