Mallet Finger FracturePO-EBPTNCT07560137
Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures
A study testing Pin-Orthosis Extension-Block Pinning Technique and Splinting in people with Mallet Finger Fracture, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mallet Finger Fracture
- What is being tested?
- Pin-Orthosis Extension-Block Pinning Technique and Splinting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2022to 15 Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Who cannot join
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
About this study
Official title: Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
Read the detailed description
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
- Conditions
- Mallet Finger Fracture
- Being tested
- Pin-Orthosis Extension-Block Pinning Technique, Splinting
- Keywords
- Conservative treatment, crawford criteria, extension-block pinning technique, mallet fracture, pin orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pin-Orthosis Extension-Block Pinning TechniqueProcedure or surgery
The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia. A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis. The fixation was maintained for a defined period, and patients were followed according to the study protocol.
SplintingProcedure or surgery
Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension. Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment (PO-EBPT) | Experimental | Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique. Receives: Procedure: Pin-Orthosis Extension-Block Pinning Technique |
| Conservative Treatment (Splinting) | Active comparator | Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint. Receives: Procedure: Splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal Interphalangeal Joint Extension Lag
Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
Measured: 12 months
Secondary outcomes (4)
Distal Interphalangeal Joint Range of Motion
Range of motion of the distal interphalangeal joint measured in degrees.
Measured: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
Functional Outcome According to Crawford Criteria
Functional outcome assessed using the Crawford classification system.
Measured: 12 months
Fracture Union
Radiographic evidence of fracture healing assessed during follow-up.
Measured: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
Complication Rate
Incidence of treatment-related complications observed during the study period.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start13 Jan 2022
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mallet Finger FractureStudies 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
- Model description
- Participants were randomly assigned to one of two parallel groups: surgical treatment using the pin-orthosis extension-block pinning technique or conservative treatment with splinting. Each participant remained in the assigned group throughout the study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Arda Çöl, Haseki Training and Research Hospital
- Investigators
- Kemal A Col, Doctor, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560137
- Sponsor's protocol ID
- 39-2022
- Acronym
- PO-EBPT
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
- ClinicalTrials.gov ID
- NCT07560137
- Acronym / sponsor ID
- PO-EBPT / 39-2022
- Conditions
- Mallet Finger Fracture
- Keywords
- Conservative treatment, crawford criteria, extension-block pinning technique, mallet fracture, pin orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 30 Apr 2026 (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.
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
Detailed description
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: surgical treatment using the pin-orthosis extension-block pinning technique or conservative treatment with splinting. Each participant remained in the assigned group throughout the study
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment (PO-EBPT) | Experimental | Procedure: Pin-Orthosis Extension-Block Pinning TechniqueParticipants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique. |
| Conservative Treatment (Splinting) | Active comparator | Procedure: SplintingParticipants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Key exclusion criteria (5 listed)
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
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 |
|---|---|---|
| Pin-Orthosis Extension-Block Pinning TechniqueThe pin-orthosis extension-block pinning technique was performed under appropriate anesthesia. A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis. The fixation was maintained for a defined period, and patients were followed according to the study protocol. | Procedure or surgery | Surgical Treatment (PO-EBPT) |
| SplintingConservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension. Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress. | Procedure or surgery | Conservative Treatment (Splinting) |
Primary outcome
Distal Interphalangeal Joint Extension Lag
Time frame: 12 months
Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
4 secondary outcomes
Distal Interphalangeal Joint Range of Motion
Time frame: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
Functional Outcome According to Crawford Criteria
Time frame: 12 months
Fracture Union
Time frame: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
Complication Rate
Time frame: Up to 12 months
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 30 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and institutional data protection policies.
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.
Kemal A Col, Doctor principal investigator
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pin-Orthosis Extension-Block Pinning Technique and Splinting in people with Mallet Finger Fracture, run by Haseki Training and Research Hospital 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 3 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 30 Apr 2026. 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?
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?
Distal Interphalangeal Joint Extension Lag (time frame: 12 months). 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 30 Apr 2026.