Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

Not Applicable

Not yet recruiting

• Conditions: Metacarpal Fracture; Phalanx Fracture
• Interventions: Procedure: Intramedullary headless screw fixation

• Registration Number: NCT06210191
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-01-07
• Study First Posted: 2024-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09
• Study Start: 2024-03
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
union of fracture	Intramedullary headless screw fixation	Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Primary Outcome Measures

Name	Time	Method
Achieve full range of motion of hand joints	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

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Assiut, Egypt