NCT07039695

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

June 18, 2025

Last Update Submit

June 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mayo Wrist Score

    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 Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) score

    3 months post-procedure

Study Arms (2)

Volar buttress plate group

EXPERIMENTAL

Patients will be treated by a volar buttress plate.

Procedure: Volar buttress plate

Herbert screw group

EXPERIMENTAL

Patients will be treated by Herbert screw.

Procedure: Herbert screw

Interventions

Patients will be treated by a volar buttress plate.

Volar buttress plate group
Herbert screwPROCEDURE

Patients will be treated by Herbert screw.

Herbert screw group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helwan University

Helwan, Cairo Governorate, 11795, Egypt

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Orthopedic Surgery, Faculty of Medicine, Helwan University, Egypt.

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

March 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations