Mallet FingerNCT05857683
Extension Pin Block vs Pin Orthosis-extension Block Pinning for Bonny Mallet Fractures
A study testing cextension pin block and pin orthosis- extension block pin in people with Mallet Finger, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This is a single center prospective study comparing the extension pin block vs pin orthosis-extension block pinning for bonny mallet fractures. 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?
- cextension pin block and pin orthosis- extension block pin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older patients
- Wehbe classification type 2 b (Type Definition) I No DIP joint subluxation II DIP joint subluxation III Epiphyseal and physeal injuries Subtype A Avulsed fragment <1/3 of articular surface B Avulsed fragment 1/3-2/3 of articular surface C Avulsed fragment >2/3 of articular surface )
- Isolated bonny mallet fractures
- Minimum 1 year follow up
- Good cognitive status
Who cannot join
- Patients under the age of 18
- Open fracture
- Chronic mallet finger
- TFracture area that includes more than 50% of the joint face
- Patients whose follow-up less than 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Medical Faculty
Ankara, 06680
Malik Kısmet, 005063436401, malikkismett@gmail.com
About this study
This is a single center prospective study comparing the extension pin block vs pin orthosis-extension block pinning for bonny mallet fractures.
Read the detailed description
Mallet finger is a fracture of the distal phalanx involving the dorsal articular surface. It is important because it concerns the extensor tendon attachment site. The clinical manifestation of mallet finger formation is active extension loss at the DIP joint. If the injury is not treated and becomes chronic, the DIP passive extension is gradually lost and a hyperextension posture occurs in the PIP joint due to the compensatory swan neck deformity. Non-surgical methods have an important place in the treatment of mallet finger injuries. The indications for surgical treatment of mallet finger injuries are a matter of debate. Conditions that are widely accepted as definite surgical indications are open injury, individuals who cannot work with a splint, the ruptured dorsal part is large and includes more than 30% of the articular surface, and the presence of palmar subluxation in the DIP. Among the mallet finger surgical treatments, the extension pin block technique , bracing in extension, hook method are defined.
In this prospective study, we aimed to compare the extension pin block technique with the pin orthosis-extension block pinning. In comparison, the patients eligible for the study will be evaluated according to Crawford criteria for function evaluation, complications (infection, nail deformities, skin necrosis, DIP joint osteoarthritis), recovery time.
- Conditions
- Mallet Finger
- Being tested
- cextension pin block, pin orthosis- extension block pin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cextension pin blockProcedure or surgery
this is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture
pin orthosis- extension block pinProcedure or surgery
this is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture
| Study group | Role | What they receive |
|---|---|---|
| extension pin block | Active comparator | this is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture Receives: Procedure: cextension pin block |
| pin orthosis- extension block pin | Active comparator | this is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture Receives: Procedure: pin orthosis- extension block pin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crawford criteria
functional scoring for the DIP joint, focuses on range of motion and pain
Measured: postoperative 1st day
Crawford criteria
functional scoring for the DIP joint, focuses on range of motion and pain
Measured: postoperative 1st month
Crawford criteria
functional scoring for the DIP joint, focuses on range of motion and pain
Measured: postoperative 3rd month
Crawford criteria
functional scoring for the DIP joint, focuses on range of motion and pain
Measured: postoperative 6th month
Crawford criteria
functional scoring for the DIP joint, focuses on range of motion and pain
Measured: postoperative 12th month
Secondary outcomes (5)
complications
skin necrosis, loss of range of motion, infection, nail bed injury
Measured: postoperative 1st day
complications
skin necrosis, loss of range of motion, infection, nail bed injury
Measured: postoperative 1st month
complications
skin necrosis, loss of range of motion, infection, nail bed injury
Measured: postoperative 3rd month
complications
skin necrosis, loss of range of motion, infection, nail bed injury
Measured: postoperative 6th month
complications
skin necrosis, loss of range of motion, infection, nail bed injury
Measured: postoperative 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mallet FingerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malik Kısmet, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857683
- Sponsor's protocol ID
- AnkaraUniHand
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data will be shared after reaching the minimum required number and performing the analysis
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Pin Block vs Pin Orthosis-extension Block Pinning for Bonny Mallet Fractures
- ClinicalTrials.gov ID
- NCT05857683
- Acronym / sponsor ID
- AnkaraUniHand
- Conditions
- Mallet Finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 May 2023 (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.
This is a single center prospective study comparing the extension pin block vs pin orthosis-extension block pinning for bonny mallet fractures.
Detailed description
Mallet finger is a fracture of the distal phalanx involving the dorsal articular surface. It is important because it concerns the extensor tendon attachment site. The clinical manifestation of mallet finger formation is active extension loss at the DIP joint. If the injury is not treated and becomes chronic, the DIP passive extension is gradually lost and a hyperextension posture occurs in the PIP joint due to the compensatory swan neck deformity. Non-surgical methods have an important place in the treatment of mallet finger injuries. The indications for surgical treatment of mallet finger injuries are a matter of debate. Conditions that are widely accepted as definite surgical indications are open injury, individuals who cannot work with a splint, the ruptured dorsal part is large and includes more than 30% of the articular surface, and the presence of palmar subluxation in the DIP. Among the mallet finger surgical treatments, the extension pin block technique , bracing in extension, hook method are defined.
In this prospective study, we aimed to compare the extension pin block technique with the pin orthosis-extension block pinning. In comparison, the patients eligible for the study will be evaluated according to Crawford criteria for function evaluation, complications (infection, nail deformities, skin necrosis, DIP joint osteoarthritis), recovery time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extension pin block | Active comparator | Procedure: cextension pin blockthis is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture |
| pin orthosis- extension block pin | Active comparator | Procedure: pin orthosis- extension block pinthis is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older patients
- Wehbe classification type 2 b (Type Definition) I No DIP joint subluxation II DIP joint subluxation III Epiphyseal and physeal injuries Subtype A Avulsed fragment <1/3 of articular surface B Avulsed fragment 1/3-2/3 of articular surface C Avulsed fragment >2/3 of articular surface )
- Isolated bonny mallet fractures
- Minimum 1 year follow up
- Good cognitive status
Key exclusion criteria (5 listed)
- Patients under the age of 18
- Open fracture
- Chronic mallet finger
- TFracture area that includes more than 50% of the joint face
- Patients whose follow-up less than 1 year
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 |
|---|---|---|
| cextension pin blockthis is the technique for mallet finger where 2 pins are used, one for the extension block and other intramedullary for the extension posture | Procedure or surgery | extension pin block |
| pin orthosis- extension block pinthis is the technique for mallet finger where only 1 pin is used for extension block and an orthosis is applied for the extension posture | Procedure or surgery | pin orthosis- extension block pin |
Primary outcome
Crawford criteria
Time frame: postoperative 1st day
functional scoring for the DIP joint, focuses on range of motion and pain
Crawford criteria
Time frame: postoperative 1st month
functional scoring for the DIP joint, focuses on range of motion and pain
Crawford criteria
Time frame: postoperative 3rd month
functional scoring for the DIP joint, focuses on range of motion and pain
Crawford criteria
Time frame: postoperative 6th month
functional scoring for the DIP joint, focuses on range of motion and pain
Crawford criteria
Time frame: postoperative 12th month
functional scoring for the DIP joint, focuses on range of motion and pain
5 secondary outcomes
complications
Time frame: postoperative 1st day
complications
Time frame: postoperative 1st month
complications
Time frame: postoperative 3rd month
complications
Time frame: postoperative 6th month
complications
Time frame: postoperative 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Yes. Collected data will be shared after reaching the minimum required number and performing the analysis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cextension pin block and pin orthosis- extension block pin in people with Mallet Finger, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 12 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malik Kısmet, MD (00905063436401, malikkismett@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crawford criteria (time frame: postoperative 1st day). The study lists 5 primary outcomes in all. 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 12 May 2023.