- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068935
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
May 15, 2023 updated by: University Children's Hospital, Zurich
Buddy Taping Compared to Splint Immobilizations for Reduced Paediatric Finger Fractures
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zürich, Switzerland, 8032
- University Children's Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 16 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Buddy taping
Buddy taping of the fractured finger to ist neighbouring uninjured finger.
|
After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization
|
|
Active Comparator: splint immobilization
A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb.
|
After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
secondary fracture displacement
Time Frame: 5 and 21 days after fracture reduction
|
X-ray controls
|
5 and 21 days after fracture reduction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient comfort
Time Frame: 5 and 21 days after fracture reduction
|
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.
|
5 and 21 days after fracture reduction
|
|
Need for analgesic medication
Time Frame: 5 and 21 days after fracture reduction
|
interview with Patient and parents
|
5 and 21 days after fracture reduction
|
|
total range of Motion
Time Frame: 6 month after fracture reduction
|
measurement
|
6 month after fracture reduction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michelle Seiler, MD, University Children's hospital, Zürich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2019
Primary Completion (Actual)
January 16, 2023
Study Completion (Actual)
January 16, 2023
Study Registration Dates
First Submitted
August 23, 2019
First Submitted That Met QC Criteria
August 23, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Buddy taping 2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fracture Finger
-
The Second Hospital of QinhuangdaoCompletedFinger Fracture | Closed Fracture of FingerChina
-
The Second Hospital of QinhuangdaoCompletedClosed Fracture of Finger | Finger Fracture OpenChina
-
Haseki Training and Research HospitalCompletedMallet Finger FractureTurkey (Türkiye)
-
Southern Health and Social Care TrustUnknownFractures, Bone | Trauma | Finger Fracture
-
Istanbul UniversityCompletedFinger Injuries | Finger Fracture | Finger MalletTurkey
-
Onur GültekinCompletedFinger Fracture | Finger Sprain | Ligament Injury of the Finger | Proximal Interphalangeal (PIP) Joint InjuryTurkey
-
Karolinska InstitutetRecruitingHand Injuries | Finger FractureSweden
-
Massachusetts General HospitalCompletedDistal Radius Fracture | Finger StiffnessUnited States
-
University of ManitobaNot yet recruitingAnesthesia, Local | Metacarpal Fracture | Finger Fracture | Fracture Fixation, Internal | Tendon Injury - Hand
-
Stanford UniversityTerminatedTrigger Finger | Trigger Finger Disorder | Trigger Thumb | Trigger Digit | Trigger Thumb, Left Thumb | Trigger Thumb, Right Thumb | Trigger Finger, Ring Finger | Trigger Finger, Index Finger | Trigger Finger, Middle Finger | Trigger Finger, Little Finger | Trigger Thumb, Unspecified Thumb | Trigger Finger, Unspecified...United States
Clinical Trials on fracture immobilization after reduction of displaced finger fractures
-
Hospital Galdakao-UsansoloCompletedHip Fracture | Elderly | Wrist Fracture