NCT06972550

Brief Summary

Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. This muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

May 3, 2025

Last Update Submit

May 13, 2025

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture

Outcome Measures

Primary Outcomes (1)

  • Radiological bone union

    an xray was done to determine if the bone ends had become united.

    2 months, 4 months

Secondary Outcomes (1)

  • pain postoperatively by the Visual Analogue Scale (VAS) score

    2 months, 4 months

Study Arms (1)

Pronator Quadratus sparing

EXPERIMENTAL

The pronator quadratus was spared during ORIF of the fracture

Procedure: pronator quadratus sparing

Interventions

pronator quadratus sparingPROCEDURE

the pronator quadratus was spared when doing orif and the plare was slided beneath it

Pronator Quadratus sparing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • isolated closed distal radius fractures

You may not qualify if:

  • fractures \>3 weeks old,
  • age \>60 years (reflecting our practice of treating most low-demand elderly patients nonoperatively unless the fracture was highly unstable),
  • pathologic fractures (e.g. metastatic lesions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 3, 2025

First Posted

May 15, 2025

Study Start

February 1, 2018

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations

EG(1)