Mallet FingerIshiguroNCT01738919
Extension Block Technique Versus Splinting in Mallet Finger Fracture.
A study testing Conservative treatment with splinting for 6 weeks. and Operative treatment with extension block technique in people with Mallet Finger, run by University of Aarhus at 1 site in Denmark.
Trial summary
Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture. Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mallet Finger
- What is being tested?
- Conservative treatment with splinting for 6 weeks. and Operative treatment with extension block technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Mallet finger fractures with a >1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
- Fractures with a delay of < 2 weeks.
- With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.
Who cannot join
- Open injuries
- Mallet finger fracture of the thumb
- Co-existing rheumatologic illness in the fingers
- No-compliance patient
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hand Surgery, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.
Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture.
Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique.
Read more
The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates.
The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.
- Conditions
- Mallet Finger
- Being tested
- Conservative treatment with splinting for 6 weeks., Operative treatment with extension block technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment with splinting for 6 weeks.Procedure or surgery
Aluminum Karstam splints are used.
Operative treatment with extension block techniqueProcedure or surgery
Also called K-wires (ø= 1 mm) are used.
Surgery with extension block technique. 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-subluxated - splinting | Active comparator | Conservative treatment with splinting for 6 weeks. Receives: Procedure: Conservative treatment with splinting for 6 weeks. |
| Non-subluxated - operation | Active comparator | Operative treatment with extension block technique Receives: Procedure: Operative treatment with extension block technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension Deficit in the Affected Distal Interphalangeal Joint.
Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)
Measured: 6 month
Secondary outcomes (5)
Pain
Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.
Measured: 6 month
Bump
Number of participants with the presence of a bump on the fracture-site.
Measured: 6 month
Complications
Number of participants with nail deformities.
Measured: 6 month
DASH
Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.
Measured: 6 month
Flexion of the Distal Interphalangeal Joint.
Flexion of the distal interphalangeal joint. Measured with goniometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2011
- Primary completionMay 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mallet FingerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bo Munk, MD, Study chair, Department of Hand Surgery, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738919
- Sponsor's protocol ID
- Janni1
- Acronym
- Ishiguro
- Status last verified
- Sep 2016
- First submitted
- 28 Nov 2012
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ishiguro Extension Block Technique Versus Splinting in the Treatment of Mallet Finger Fracture. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01738919
- Acronym / sponsor ID
- Ishiguro / Janni1
- Conditions
- Mallet Finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 4 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture.
Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique.
The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates.
The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-subluxated - splinting | Active comparator | Procedure: Conservative treatment with splinting for 6 weeks.Conservative treatment with splinting for 6 weeks. |
| Non-subluxated - operation | Active comparator | Procedure: Operative treatment with extension block techniqueOperative treatment with extension block technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Mallet finger fractures with a >1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges.
- Fractures with a delay of < 2 weeks.
- With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.
Key exclusion criteria (4 listed)
- Open injuries
- Mallet finger fracture of the thumb
- Co-existing rheumatologic illness in the fingers
- No-compliance patient
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 |
|---|---|---|
| Conservative treatment with splinting for 6 weeks.Aluminum Karstam splints are used. | Procedure or surgery | Non-subluxated - splinting |
| Operative treatment with extension block techniqueAlso: K-wires (ø= 1 mm) are used.Surgery with extension block technique. 6 weeks. | Procedure or surgery | Non-subluxated - operation |
Primary outcome
Extension Deficit in the Affected Distal Interphalangeal Joint.
Time frame: 6 month
Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)
5 secondary outcomes
Pain
Time frame: 6 month
Bump
Time frame: 6 month
Complications
Time frame: 6 month
DASH
Time frame: 6 month
Flexion of the Distal Interphalangeal Joint.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Bo Munk, MD study chair
Department of Hand Surgery, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment with splinting for 6 weeks. and Operative treatment with extension block technique in people with Mallet Finger, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 4 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 4 Nov 2016. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extension Deficit in the Affected Distal Interphalangeal Joint. (time frame: 6 month). 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 4 Nov 2016.