Fracture FingerNCT04068935
Buddy Taping Compared to Splint Immobilization for Displaced Paediatric Finger Fractures
A study testing fracture immobilization after reduction of displaced finger fractures in people with Fracture Finger, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Fracture Finger
- What is being tested?
- fracture immobilization after reduction of displaced finger fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Aug 2019to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- extraarticular displaced finger fractures of the proximal or middle phalanges
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fracture Finger
- Being tested
- fracture immobilization after reduction of displaced finger fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fracture immobilization after reduction of displaced finger fracturesProcedure or surgery
After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization
| Study group | Role | What they receive |
|---|---|---|
| Buddy taping | Experimental | Buddy taping of the fractured finger to ist neighbouring uninjured finger. Receives: Procedure: fracture immobilization after reduction of displaced finger fractures |
| splint immobilization | Active comparator | A forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb. Receives: Procedure: fracture immobilization after reduction of displaced finger fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary fracture displacement
X-ray controls
Measured: 5 and 21 days after fracture reduction
Secondary outcomes (3)
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.
Measured: 5 and 21 days after fracture reduction
Need for analgesic medication
interview with Patient and parents
Measured: 5 and 21 days after fracture reduction
total range of Motion
measurement
Measured: 6 month after fracture reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start20 Aug 2019
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Seiler, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068935
- Sponsor's protocol ID
- Buddy taping 2019
- Status last verified
- May 2023
- First submitted
- 23 Aug 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buddy Taping Compared to Splint Immobilizations for Reduced Paediatric Finger Fractures
- ClinicalTrials.gov ID
- NCT04068935
- Acronym / sponsor ID
- Buddy taping 2019
- Conditions
- Fracture Finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buddy taping | Experimental | Procedure: fracture immobilization after reduction of displaced finger fracturesBuddy taping of the fractured finger to ist neighbouring uninjured finger. |
| splint immobilization | Active comparator | Procedure: fracture immobilization after reduction of displaced finger fracturesA forearm-based palmar Hand Splint in an intrinsic plus Position, enclosing all fingers without the thumb. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- extraarticular displaced finger fractures of the proximal or middle phalanges
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fracture immobilization after reduction of displaced finger fracturesAfter closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization | Procedure or surgery | Buddy taping, splint immobilization |
Primary outcome
secondary fracture displacement
Time frame: 5 and 21 days after fracture reduction
X-ray controls
3 secondary outcomes
Patient comfort
Time frame: 5 and 21 days after fracture reduction
Need for analgesic medication
Time frame: 5 and 21 days after fracture reduction
total range of Motion
Time frame: 6 month after fracture reduction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Fracture Finger
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Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
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Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.
Proximal Interphalangeal Joint Fracture
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Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
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Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
Pediatric Overriding Distal Metaphyseal Radius Fractures
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Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting
Boxer's Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Seiler, MD principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fracture immobilization after reduction of displaced finger fractures in people with Fracture Finger, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary fracture displacement (time frame: 5 and 21 days after fracture reduction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.