NCT06723483

Brief Summary

using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress88%
Jan 2024Sep 2026

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

October 3, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

bridging plate, distraction plate

Outcome Measures

Primary Outcomes (1)

  • Modified Mayo Wrist Score (MMWS)

    Combines subjective and objective parameters to evaluate wrist functionality.

    Mean follow-up period is 1 year postoperative.

Secondary Outcomes (1)

  • Wrist Range of Movement

    Mean follow-up period is 1 year postoperative.

Interventions

This technique deals with comminuted distal radius fracture using a distraction plate. The plate was inserted by minimally invasive skin incisions, fixed from the 2end metacarpal distally to the 2end extensor compartment at intact radius proximally Spaning the comminution, Restoring the Radial Length, Radial Inclination, Volar Tilt

Also known as: bride plating, bridging plate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

oFirst peak is the young exposed to high energy trauma , fall from a height, polytrauma patients with extensive communition of metaphyseal and articular parts oSecond peak is old (over 60 years),with osteoporotic bone where even minor falls can cause extensive comminution

You may qualify if:

  • Skeletally mature patients
  • presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
  • articular with or without metaphyseal comminution
  • Very distal fractures 5 )osteoporotic bone fractures

You may not qualify if:

  • Dorsal soft tissue defect or tendon injuries
  • Metacarpal fractures (esp 2end MC)
  • open grade 3 fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine assuit university

Asyut, Egypt

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Waleed Riad Saleh Waleed Riad Saleh Ramadan, preso doctor

    assiut university hospitals

    STUDY CHAIR
  • Yasser Farouk Yasser Mohamed Farouk Fouad Ragheb, doctor

    assiut university hospitals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 3, 2024

First Posted

December 9, 2024

Study Start

January 1, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations