- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523386
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
A Comparative Study Between Cannulated Screws and K-wires in the Treatment of Distal Radius Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Mahmoud Tammam, Practiciant
- Phone Number: 01020745267
- Email: ahmd.tamam2425@gmail.com
Study Locations
-
-
Naser City
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Sohag, Naser City, Egypt
- Recruiting
- Sohag University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 |
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-3-2MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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