NCT07523386

Brief Summary

This comparative study aims to evaluate the clinical and radiological outcomes of cannulated screw fixation versus K-wire fixation in the treatment of distal radius fractures. Adult patients with distal radius fractures will be allocated to either cannulated screw fixation or K-wire fixation. The primary outcome measure will be functional outcome assessed using the DASH score, with secondary outcomes including radiographic parameters and complication rates.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress37%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

April 22, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2027

Last Updated

April 20, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

April 5, 2026

Last Update Submit

April 15, 2026

Conditions

Distal Radius Fractures

Keywords

Distal Radius FracturesCannulated screwsColles'

Outcome Measures

Primary Outcomes (2)

  • 1. Radiological union

    Number of patients achieving complete bone healing as assessed by serial X-rays (presence of bridging callus on 3 out of 4 cortices). Unit of Measure: Number of Participants.

    6months postoperatively

  • Mean Hand Grip Strength

    Measurement of the physical force of the hand using a calibrated Jamar hydraulic hand dynamometer. The average of three successive trials with the affected hand will be recorded. Unit of Measure: Kilograms.

    6months postoperatively

Study Arms (2)

Cannulated Screw Fixation

OTHER

Arm 1: Cannulated Screw Fixation Description: Patients in this group will undergo surgical fixation of distal radius fractures using cannulated screws. Postoperative functional outcomes will be assessed using the DASH score at 6 months. Radiographic alignment (radial height, radial inclination, and volar tilt) and complication rates will also be recorded

Procedure: Cannulated screw Fixation In Treatment Of Distal Radius

K-wire fixation

NO INTERVENTION

Patients in this group will undergo surgical fixation of distal radius fractures using percutaneous K-wires. The procedure involves closed reduction followed by insertion of K-wires under fluoroscopic guidance. Postoperative care includes immobilization and physiotherapy. Functional outcomes will be assessed using the DASH score at 6 months, and radiographic alignment and complication rates will be monitored.

Interventions

Cannulated screw Fixation In Treatment Of Distal RadiusPROCEDURE

Patients assigned to this group will undergo surgical fixation of distal radius fractures using cannulated screws. The procedure involves open reduction and internal fixation with appropriate screw placement under fluoroscopic guidance. Postoperative care includes standard immobilization, physiotherapy, and follow-up visits to assess functional recovery using the DASH score and radiographic alignment. Complications such as infection, malunion, or hardware failure will be monitored.

Cannulated Screw Fixation

Eligibility Criteria

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

You may qualify if:

  • Patients aged between 18\_60years.
  • Patients with displaced or unstable Distal Radius Fractures requiring surgical Fixation.
  • Type A Extra articular Fractures.
  • Patients fit for surgery and willing to participate in the study.

You may not qualify if:

  • open distal Radius Fractures.
  • Pathological Fractures.
  • Previous Fractures or surgeries affecting the wrist.
  • Associated neurovascular injury.
  • polytrauma patient.
  • Patients with severe osteoporotic or systemic condition affecting bone healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Naser City, Egypt

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

Ahmed Mahmoud Tammam, Practiciant

CONTACT

01020745267ahmd.tamam2425@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopedic Surgery

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

January 22, 2027

Study Completion (Estimated)

January 23, 2027

Last Updated

April 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

EG(1)