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

Study Overview

• Status: Recruiting
• Conditions: Acute Bony Mallet Finger
• Intervention / Treatment: Procedure: surgical fixation of acute bony mallet finger

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa A Ahmed, resident; Phone Number: 01146002527; Email: mostafa_ahmed_post@med.sohag.edu.eg
• Study Contact Backup: Name: Hassan N Noaman, professor; Phone Number: 01002554984

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A : acute bony mallet finger managed by micro plate fixation	Procedure: surgical 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
Active Comparator: Group B; Group B : Acute bony mallet finger managed by blocking k.wire fixation	Procedure: surgical 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): October 25, 2024
• Study Completion (Estimated): October 25, 2024

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-24-04-06MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No