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Clinical Trials/NCT06210191
NCT06210191
Not yet recruiting
Not Applicable

Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

Assiut University1 site in 1 country35 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metacarpal Fracture
Sponsor
Assiut University
Enrollment
35
Locations
1
Primary Endpoint
Achieve full range of motion of hand joints
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
March 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdelrahman Megahed Ahmed

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Skeletally mature patients with closed fractures of phalanges and metacarpals.
  • Patients with open type I fractures of phalanges and metacarpals.

Exclusion Criteria

  • Skeletally immature patients with open physis.
  • Patients with open type II or III fractures of phalanges or metacarpals.
  • Patients with fractures of phalanges or metacarpals with neurovascular injury. 4 Patients with associated tendon injuries.

Outcomes

Primary Outcomes

Achieve full range of motion of hand joints

Time Frame: 6 weeks for active range of motion

Change DASH Score of hand functions to 0 by this intervention. As 0 is excellent and 100 is the worst outcome

Study Sites (1)

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