Volar Carbon Plate Effects on Procedure Time

The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures

Radius distal end fractures are common orthopedic injuries. Many methods have been described in the treatment of distal radius fractures. The fixation of radius distal end fracture with volar plate was first applied by Ellis in 1965. Over the years, ideas have been put forward on the materials used for plates and the radiolucent carbon fiber plates has been used. These plates cause less artifact in computed tomography (CT) and magnetic resonance examinations (MRI), allow a better evaluation of the fracture, exhibit biomechanical characteristics close to the cortical bone, and do not cause a coldwedding in patients.

Study Overview

• Status: Completed
• Conditions: Surgery; Radiation Exposure; Radius Distal Fracture
• Intervention / Treatment: Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures

Detailed Description

Titanium alloy plates are frequently used materials in our current orthopedic surgery practices. The main goal during surgical treatment is to obtain an accurate and acceptable bone alignment. Achieving this goal as soon as possible will reduce additional morbidity and mortality and increase the success of treatment. Therefore, studies aiming to reduce the operation time come to the fore. When the literature is examined, there are limited number of studies on carbon plates. In these studies, it was reported that similar functional results were obtained with titanium alloy plates. Although the bones are at the surgeon's disposal in plate fixation of radius distal end fractures, fluoroscopy is frequently used for reduction control. The increase in the need for scopy both directly affects the duration of the operation and causes the surgical team to be exposed to excessive radiation. Since titanium alloy plates are radiopaque, they create a superposition to the fracture line and more than one view is usually required in each plane to ensure the reduction quality during surgery. Carbon alloy plates, on the other hand, offer the advantage of faster radiological reduction control because they do not create superposition to the fracture line. In our study, in addition to the comparisons in the literature, it is aimed to investigate the effect of carbon plates on the procedure time. For this purpose, distal radius fractured patients applied to our clinic will be treated with titanium and carbon plates after the necessary randomization. After the tourniquet is applied, the time elapsed until the fixation is completed, the duration of scopy, and the number of scopy images taken will be recorded. In the follow-ups, the functional scores and radiological measurements of the patients will be made and the complications will be evaluated.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25000
    • Atatürk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Radius distal simple intraarticular fractures
• Closed fractures

Exclusion Criteria:

• Acompanying fracture at the same limb
• Open fractures
• Pathological fractures
• The patients who don't want to be included in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volar Carbon Plate Effects on Procedure Time; Carbon alloy plates, offer the advantage of faster radiological reduction control because they do not create superposition to the fracture line	Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures; Surgery procedure, Although the bones are at the surgeon's disposal in plate fixation of radius distal end fractures, fluoroscopy is frequently used for reduction control. The increase in the need for scopy both directly affects the duration of the operation and causes the surgical team to be exposed to excessive radiation. Since titanium alloy plates are radiopaque, they create a superposition to the fracture line and more than one view is usually required in each plane to ensure the reduction quality during surgery. Carbon alloy plates, on the other hand, offer the advantage of faster radiological reduction control because they do not create superposition to the fracture line. In our study, in addition to the comparisons in the literature, it is aimed to investigate the effect of carbon plates on the procedure time. surgery time and exposure of radiation will be recorded at the end of the surgery; Other Names: Titanium Alloy Plate surgery; Carbon Alloy Plate surgery
Active Comparator: Titanium Alloy Plates Group; Titanium alloy plates are frequently used materials in our current orthopedic surgery practices. The main goal during surgical treatment is to obtain an accurate and acceptable bone alignment. Since titanium alloy plates are radiopaque, they create a superposition to the fracture line and more than one view is usually required in each plane to ensure the reduction quality during surgery.	Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures; Surgery procedure, Although the bones are at the surgeon's disposal in plate fixation of radius distal end fractures, fluoroscopy is frequently used for reduction control. The increase in the need for scopy both directly affects the duration of the operation and causes the surgical team to be exposed to excessive radiation. Since titanium alloy plates are radiopaque, they create a superposition to the fracture line and more than one view is usually required in each plane to ensure the reduction quality during surgery. Carbon alloy plates, on the other hand, offer the advantage of faster radiological reduction control because they do not create superposition to the fracture line. In our study, in addition to the comparisons in the literature, it is aimed to investigate the effect of carbon plates on the procedure time. surgery time and exposure of radiation will be recorded at the end of the surgery; Other Names: Titanium Alloy Plate surgery; Carbon Alloy Plate surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedures Time	Time elapsed in minutes between the starting of the surgical procedure and the fixation time.	0-1 hours of the surgery
Radiation Exposure	Time elapsed in minutes during the surgery	0-1 hours of the surgery
Functional Outcome	wrist flexion degree measurement with goniometer , wrist extension degree measurement with goniometer , ulnar deviation degree measurement with goniometer and radial deviation degree measurement with goniometer and measurement with a hand grip strength dynamometer	At the end of the 2nd week
Functional Outcome	wrist flexion degree measurement with goniometer , wrist extension degree measurement with goniometer , ulnar deviation degree measurement with goniometer and radial deviation degree measurement with goniometer and measurement with a hand grip strength dynamometer	At the end of the 5th week
Functional Outcome	wrist flexion, extension, ulnar deviation and radial deviation degree measurement with wrist flexion degree measurement with goniometer , wrist extension degree measurement with goniometer , ulnar deviation degree measurement with goniometer and radial deviation degree measurement with goniometer and measurement with a hand grip strength dynamometer	At the end of the 3rd month
Functional Outcome	wrist flexion degree measurement with goniometer , wrist extension degree measurement with goniometer , ulnar deviation degree measurement with goniometer and radial deviation degree measurement with goniometer and measurement with a hand grip strength dynamometer	At the end of the 6th month

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: surgery; radiation; carbon plate; radius distal
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No