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RecruitingNCT06398483Updated May 3, 2024

Comparative Study Between Micro Plate Fixation and Blocking k.Wire in Management of Acute Bony Mallet Finger : Randomized Controlled Clinical Trial Study

An interventional study of surgical fixation of acute bony mallet finger in Acute Bony Mallet Finger, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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 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

02

Conditions studied

  • Acute Bony Mallet Finger
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Acute bony mallet finger involves more than one third of the distal phalanx joint surface or the distal phalanx becomes volar sublaxed

Exclusion criteria

Exclusion Criteria:

1- . crushed distal phalanx 2. soft tissue mallet 3. multiple phalangeal fractures 4. old neglected cases

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Group A

    Group A : acute bony mallet finger managed by micro plate fixation

    Procedure: surgical fixation of acute bony mallet finger

  • Active comparator
    Group B

    Group B : Acute bony mallet finger managed by blocking k.wire fixation

    Procedure: surgical fixation of acute bony mallet finger

Interventions

  • Proceduresurgical fixation of acute bony mallet finger

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sohag university Hospital
    Sohag, Egypt
    • Magdy M Amin, professor · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06398483
Lead sponsor
Sohag University
Responsible party
Mostafa Ahmed Mohamed Elsadik (Resident at orthopedics and trauma surgery department, Sohag University) — Principal investigator
First posted
May 3, 2024
Start date
Apr 25, 2024
Primary completion
Oct 25, 2024 (estimated)
Completion
Oct 25, 2024 (estimated)
Last update
May 3, 2024

Study contacts

Mostafa A Ahmed, resident
Contact
mostafa_ahmed_post@med.sohag.edu.eg
01146002527
Hassan N Noaman, professor
Contact
01002554984

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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