NCT07108543

Brief Summary

This study aims to compare the clinical and radiological outcomes of distal radius fractures treated with cross K-wire fixation using the antegrade versus retrograde technique. Adult patients with extra-articular distal radius fractures will be randomly assigned to one of the two surgical approaches. The primary outcomes include fracture stability, functional recovery, and complication rates. The study is designed as a prospective, randomized controlled trial conducted at sohag university

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 30, 2025

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiological union of distal radius fracture

    Radiographic healing will be assessed using standard X-rays to evaluate union status. Radiographs will be reviewed for signs of cortical continuity and absence of fracture lines

    At 6 weeks, 3 months, and 6 months postoperatively

Secondary Outcomes (2)

  • Functional outcome using DASH score

    At 6 weeks, 3 months, and 6 months postoperatively

  • Pain level using Visual Analog Scale (VAS)

    At 1 week, 6 weeks, 3 months, and 6 months postoperatively

Study Arms (2)

Arm 1 Title: Antegrade K-wire Fixation

EXPERIMENTAL

participants in this group will undergo antegrade percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from proximal to distal direction under fluoroscopic guidance, following closed reduction

Procedure: Antegrade versus retrograde cross k-wire

Arm 2 Title: Retrograde K-wire Fixation

EXPERIMENTAL

Participants in this group will undergo retrograde percutaneous cross K-wire fixation for distal radius fractures. K-wires will be inserted from distal to proximal direction under fluoroscopic guidance, following closed reduction

Procedure: Antegrade versus retrograde cross k-wire

Interventions

\> Closed reduction of distal radius fracture followed by percutaneous insertion of two or more K-wires in an antegrade direction (from proximal to distal), crossing the fracture site under fluoroscopic guidance. The wires are introduced from the radial metaphysis and directed distally to stabilize the fracture.

Arm 1 Title: Antegrade K-wire FixationArm 2 Title: Retrograde K-wire Fixation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with extra-articular distal radius fractures. Fractures classified as Frykmann type 1 and type 2. Patients aged 18 years and above.

You may not qualify if:

  • Skeletally immature patient.
  • Intra-articular distal radius fractures.
  • Communited fractures.
  • Open fractures or fractures with neurovascular compromise.
  • Patients with fractures requiring surgical interventions other than K-wire fixation.
  • Patients with a history of infection or other conditions impair wound healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Montasser T Omar, resident

CONTACT

Elshazly S Mousa, professer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial using a parallel assignment model. Participants will be randomly assigned to one of two groups: Group A will undergo cross K-wire fixation using the antegrade technique, and Group B will undergo the retrograde technique. Outcomes will be compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident orthopeadics sohag university

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 7, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07