Volar Carbon Plate Effects on Procedure Time

NCT05630430 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Exposure; Surgery; Radius Distal Fracture

Keywords

carbon plate; radius distal; radiation; surgery

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Volar Carbon Plate Effects on Procedure Time

EXPERIMENTAL

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

Titanium Alloy Plates Group

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: Titanium Alloy Plate surgery, Carbon Alloy Plate surgery

Titanium Alloy Plates Group; Volar Carbon Plate Effects on Procedure Time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radius distal simple intraarticular fractures
• Closed fractures

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: November 29, 2022
• Study Start: April 1, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 28, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)