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NCT Number: NCT05630430

Volar Carbon Plate Effects on Procedure Time

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.

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Key information

Conditions

Radiation Exposure Arm Injuries Fractures, Bone Radius Distal Fracture Surgery Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Titanium Alloy Plate surgery, Carbon Alloy Plate surgery

Primary outcomes

  1. Procedures Time

    Time frame: 0-1 hours of the surgery

    Time elapsed in minutes between the starting of the surgical procedure and the fixation time.

  2. Radiation Exposure

    Time frame: 0-1 hours of the surgery

    Time elapsed in minutes during the surgery

  3. Functional Outcome

    Time frame: At the end of the 2nd week

    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

  4. Functional Outcome

    Time frame: At the end of the 5th week

    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

  5. Functional Outcome

    Time frame: At the end of the 3rd month

    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

  6. Functional Outcome

    Time frame: At the end of the 6th month

    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

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 29, 2022
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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