Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures

April 15, 2026 updated by: Ahmed Mahmoud Tammam, Sohag University

A Comparative Study Between Cannulated Screws and K-wires in the Treatment of Distal Radius Fractures

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Distal radius fractures are among the most common orthopedic injuries in adults. Various fixation techniques are used depending on fracture pattern and surgeon preference. Cannulated screw fixation and K-wire fixation are minimally invasive techniques commonly used in selected fracture types; however, there is ongoing debate regarding their comparative effectiveness in terms of functional recovery and complication rates.

This prospective comparative study will include patients diagnosed with distal radius fractures who meet the inclusion criteria. Participants will be allocated into two groups: Group A will undergo fixation using cannulated screws, and Group B will undergo fixation using K-wires. Patients will be followed for a period of 6 months postoperatively.

The primary outcome will be functional assessment using the DASH score at 6 months. Secondary outcomes will include radiographic parameters (radial height, radial inclination, and volar tilt), time to union, and postoperative complications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Naser City
      • Sohag, Naser City, Egypt
        • Recruiting
        • Sohag university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cannulated Screw Fixation

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
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.
No Intervention: K-wire fixation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1. Radiological union
Time Frame: 6months postoperatively

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
Time Frame: 6months postoperatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-26-3-2MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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