Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures

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

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.

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