Acute Bony Mallet FingerNCT06398483
Comparative Study Between Micro Plate Fixation and Blocking k.Wire in Management of Acute Bony Mallet Finger : Randomized Controlled Clinical Trial Study
A study testing surgical fixation of acute bony mallet finger in people with Acute Bony Mallet Finger, run by Sohag University at 1 site in Egypt.
Trial summary
Mallet finger is an avulsion fracture of the distal phalanx or rupture of the extensor terminal band caused by distal interphalangeal (DIP) joint hyperflexion or axial loading. In the treatment of mallet finger fractures, surgical repair is recommended in cases where the fracture involves more than one-third of the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Bony Mallet Finger
- What is being tested?
- surgical fixation of acute bony mallet finger
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 25 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Acute bony mallet finger involves more than one third of the distal phalanx joint surface or the distal phalanx becomes volar sublaxed
Who cannot join
- 1- . crushed distal phalanx 2. soft tissue mallet 3. multiple phalangeal fractures 4. old neglected cases
Trial locations and contacts
1 site in 1 country.
Hassan N Noaman, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Mallet finger is an avulsion fracture of the distal phalanx or rupture of the extensor terminal band caused by distal interphalangeal (DIP) joint hyperflexion or axial loading. In the treatment of mallet finger fractures, surgical repair is recommended in cases where the fracture involves more than one-third of the distal phalanx joint surface or the distal phalanx becomes volar subluxated
The blocking k.wire and micro plate technique are some of the methods used in the treatment of mallet finger fractures In recent years, the blocking k.wire technique has gained popularity owing to its minimally invasive nature and its ability to achieve satisfactory postoperative results
The main advantages of Micro Plate technique include provision of anatomical reduction and stable fixation, avoiding the risk of fragmentation of the small dorsal fragment, allowing early movement and increasing patient comfort and compliance
- Conditions
- Acute Bony Mallet Finger
- Being tested
- surgical fixation of acute bony mallet finger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical fixation of acute bony mallet fingerProcedure or surgery
surgical fixation of acute bony mallet finger by micro plate will be performed under either Infraclavicular nerve blockage or digital block will be performed in all patients .fracture fragment will be reduced, The legs of the plate will be embedded in the terminal tendon to grasp the fragment. The plate will be fixed to the distal phalanx with a 1.3-mm screw.
surgical fixation of acute bony mallet finger by blocking K.wire will be performed under either infraclavicular nerve block or digital block. The injury will be surgically intervened with an extensor blocking k.wire. the distal phalanx was extended to maximum flexion and (K.wire) will be placed in the cephalic direction through the terminal band at an angle of 45 degrees to the mid-phalanx. Reduction of the fracture fragment will be achieved by bringing the distal phalanx to extension . the DIP will be transfixed with a second K-wire
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A : acute bony mallet finger managed by micro plate fixation Receives: Procedure: surgical fixation of acute bony mallet finger |
| Group B | Active comparator | Group B : Acute bony mallet finger managed by blocking k.wire fixation Receives: Procedure: surgical fixation of acute bony mallet finger |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative evalution of management of acute bony mallet finger
Clinical evaluation of improvement of pain , deformity , range of motion , incidence of surgical site infection , radiographic union time
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 posted3 May 2024
- Study start25 Apr 2024
- Primary completion25 Oct 2024 (estimated)
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bony Mallet 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ahmed Mohamed Elsadik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398483
- Sponsor's protocol ID
- Soh-Med-24-04-06MS
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Micro Plate Fixation and Blocking k.Wire in Management of Acute Bony Mallet Finger : Randomized Controlled Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06398483
- Acronym / sponsor ID
- Soh-Med-24-04-06MS
- Conditions
- Acute Bony Mallet Finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 3 May 2024 (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 is an avulsion fracture of the distal phalanx or rupture of the extensor terminal band caused by distal interphalangeal (DIP) joint hyperflexion or axial loading. In the treatment of mallet finger fractures, surgical repair is recommended in cases where the fracture involves more than one-third of the distal phalanx joint surface or the distal phalanx becomes volar subluxated
The blocking k.wire and micro plate technique are some of the methods used in the treatment of mallet finger fractures In recent years, the blocking k.wire technique has gained popularity owing to its minimally invasive nature and its ability to achieve satisfactory postoperative results
The main advantages of Micro Plate technique include provision of anatomical reduction and stable fixation, avoiding the risk of fragmentation of the small dorsal fragment, allowing early movement and increasing patient comfort and compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: surgical fixation of acute bony mallet fingerGroup A : acute bony mallet finger managed by micro plate fixation |
| Group B | Active comparator | Procedure: surgical fixation of acute bony mallet fingerGroup B : Acute bony mallet finger managed by blocking k.wire fixation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute bony mallet finger involves more than one third of the distal phalanx joint surface or the distal phalanx becomes volar sublaxed
Key exclusion criteria (1 listed)
- 1- . crushed distal phalanx 2. soft tissue mallet 3. multiple phalangeal fractures 4. old neglected cases
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 |
|---|---|---|
| surgical fixation of acute bony mallet fingersurgical fixation of acute bony mallet finger by micro plate will be performed under either Infraclavicular nerve blockage or digital block will be performed in all patients .fracture fragment will be reduced, The legs of the plate will be embedded in the terminal tendon to grasp the fragment. The plate will be fixed to the distal phalanx with a 1.3-mm screw. surgical fixation of acute bony mallet finger by blocking K.wire will be performed under either infraclavicular nerve block or digital block. The injury will be surgically intervened with an extensor blocking k.wire. the distal phalanx was extended to maximum flexion and (K.wire) will be placed in the cephalic direction through the terminal band at an angle of 45 degrees to the mid-phalanx. Reduction of the fracture fragment will be achieved by bringing the distal phalanx to extension . the DIP will be transfixed with a second K-wire | Procedure or surgery | Group A, Group B |
Primary outcome
post operative evalution of management of acute bony mallet finger
Time frame: 6 months
Clinical evaluation of improvement of pain , deformity , range of motion , incidence of surgical site infection , radiographic union time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Undecided
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.
Hassan N Noaman, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical fixation of acute bony mallet finger in people with Acute Bony Mallet Finger, run by Sohag University at 1 site in Egypt.
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 1 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 3 May 2024. 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 Egypt. 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 Mostafa A Ahmed, resident (01146002527, mostafa_ahmed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative evalution of management of acute bony mallet finger (time frame: 6 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 3 May 2024.