Intramedullary Headless Screw Fixation for Metacarpal and Phalangeal Fractures

February 8, 2024 updated by: Ahmed Abdelrahman Megahed Ahmed, Assiut University
Intramedullary headless screw fixation for metacarpal and phalangeal fractures

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: union of fracture
Intramedullary headless screw fixation for metacarpal and phalangeal fractures
Procedure: Intramedullary headless screw fixation
fixation of fractures of metacarpals and phalanges by intramedullary headless screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks for active range of motion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Amr Elsayed, professor, Assiut University
  • Study Director: Waleed Riad, professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intramedullary screw fixation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available. all collected IPD, all IPD that underlie results in a publication)

IPD Sharing Time Frame

starting in January 2025 or as a date relative to the time when summary data are published

IPD Sharing Access Criteria

access criteria of my IPD will be available with my investigators

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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