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

NCT ID: NCT06398483

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2024-10-25

Brief 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

Conditions

Acute Bony Mallet Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

surgical fixation of acute bony mallet finger

Intervention Type: PROCEDURE

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

Group B

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

Group Type: ACTIVE_COMPARATOR

surgical fixation of acute bony mallet finger

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Ahmed Mohamed Elsadik

Resident at orthopedics and trauma surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa A Ahmed, resident

Role: CONTACT

mostafa_ahmed_post@med.sohag.edu.eg

01146002527

Hassan N Noaman, professor

Role: CONTACT

01002554984

Facility Contacts

Magdy M Amin, professor

Role: primary

Other Identifiers

Soh-Med-24-04-06MS

Identifier Type: -

Identifier Source: org_study_id