Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate

June 18, 2025 updated by: Khaled Karam Abed El-Aleem Mohammed, Helwan University

Evaluation of Union Rate of Scaphoid Non-Union Fracture in Adults by Herbert Screw Versus Volar Buttress Plate

This study aimed to evaluate the short-term results of treating non-united scaphoid waist fractures with a humpback deformity by graft and internal fixation using a volar buttress plate versus the use of a Herbert screw.

Study Overview

Detailed Description

Scaphoid fracture is the most common fracture, accounting for roughly 60% of the total carpal bone fractures and 11 % of all hand fractures.

Nonunion occurs in approximately 5% to 25 % of scaphoid fractures. The scaphoid nonunion will collapse into a humpback deformity, and the lunate, together with the proximal pole, into a dorsal intercalated segment instability, which might end in an advanced carpal collapse.

A scaphoid screw acts to prevent bending at the fracture site with three-point fixation within the cancellous bone of the scaphoid. The proximal and distal points of purchase are achieved by the capture of the screw threads in the cancellous bone of the proximal and distal poles of the scaphoid. The third point occurs within the cancellous bone of the scaphoid waist.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

    • Cairo
      • Helwan, Cairo, Egypt, 11795
        • Helwan University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of a patient is between 20 years to 50 years.
  • Non-union or delayed union scaphoid wrist fracture (more than 3 months).
  • Closed fracture.
  • Patients without previous scaphoid surgery.
  • Patients without abnormal renal and/or liver functions.
  • Patients without hypocalcemia and/or vitamin D3 deficiency.

Exclusion Criteria:

  • Open fracture.
  • Patients with proximal or distal fracture of the scaphoid.
  • Patients with avascular necrosis of scaphoid.
  • Patients with mid-carpal arthritis or pan-carpal arthritis.
  • Patients with carpal instability.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volar buttress plate group
Patients will be treated by a volar buttress plate.
Patients will be treated by a volar buttress plate.
Experimental: Herbert screw group
Patients will be treated by Herbert screw.
Patients will be treated by Herbert screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mayo Wrist Score
Time Frame: 3 months post-procedure
The Mayo Wrist Score is a fast and simple tool comprising four questions that assess pain intensity, wrist function, range of motion, and grip strength. Mayo Wrist Score ranges from 0 to 100. Scores of 90-100 are considered excellent, 80-90 good, 60-80 satisfactory, and below 60 poor.
3 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time Frame: 3 months post-procedure
The Disabilities of the Arm, Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. The score is calculated on a scale score ranging from 0 (no disability) to 100 (most severe disability).
3 months post-procedure

Collaborators and Investigators

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

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 (Actual)

March 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 18, 2025

First Submitted That Met QC Criteria

June 18, 2025

First Posted (Estimated)

June 26, 2025

Study Record Updates

Last Update Posted (Estimated)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 10-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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