Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

Metacarpal Fracture Clinical Trial

Official title:

Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210191
• Other study ID #: Intramedullary screw fixation
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Ahmed Megahed, resident
• Phone: +201007712309
• Email: megahed117[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Description:

The most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency.

There are many methods of fixation of these fractures as plates and K-wires. Plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. Reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag.

There are minimally invasive techniques, including the use of K-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. These options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness.

Intramedullary headless screw fixation is an emerging alternative to K-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. The Intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. Due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications.

Beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Skeletally mature patients with closed fractures of phalanges and metacarpals.

2. Patients with open type I fractures of phalanges and metacarpals.

Exclusion Criteria:

1. Skeletally immature patients with open physis.

2. Patients with open type II or III fractures of phalanges or metacarpals.

3. Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.

Related Conditions & MeSH terms

• Fractures, Bone
• Metacarpal Fracture

Intervention

Procedure:
• Intramedullary headless screw fixation
fixation of fractures of metacarpals and phalanges by intramedullary headless screws

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieve full range of motion of hand joints	Change DASH Score of hand functions to 0 by this intervention. As 0 is excellent and 100 is the worst outcome	6 weeks for active range of motion