Radiation ExposureNCT05630430
Volar Carbon Plate Effects on Procedure Time
A study testing The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures in people with Radiation Exposure and Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure, Surgery, Radius Distal Fracture
- What is being tested?
- The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radius distal simple intraarticular fractures
- Closed fractures
Who cannot join
- Acompanying fracture at the same limb
- Open fractures
- Pathological fractures
- The patients who don't want to be included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation Exposure, Surgery, Radius Distal Fracture
- Being tested
- The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures
- Keywords
- carbon plate, radius distal, radiation, surgery
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End FracturesProcedure or surgery
Also called Titanium Alloy Plate surgery, Carbon Alloy Plate surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedures Time
Time elapsed in minutes between the starting of the surgical procedure and the fixation time.
Measured: 0-1 hours of the surgery
Radiation Exposure
Time elapsed in minutes during the surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of the 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Apr 2021
- Primary completion5 May 2023
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Cagatay Engin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630430
- Sponsor's protocol ID
- 1
- Status last verified
- May 2024
- First submitted
- 29 Mar 2022
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures
- ClinicalTrials.gov ID
- NCT05630430
- Acronym / sponsor ID
- 1
- Conditions
- Radiation Exposure, Surgery, Radius Distal Fracture
- Keywords
- carbon plate, radius distal, radiation, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar Carbon Plate Effects on Procedure Time | Experimental | Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End FracturesCarbon alloy plates, offer the advantage of faster radiological reduction control because they do not create superposition to the fracture line |
| Titanium Alloy Plates Group | Active comparator | Procedure: The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End FracturesTitanium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Radius distal simple intraarticular fractures
- Closed fractures
Key exclusion criteria (4 listed)
- Acompanying fracture at the same limb
- Open fractures
- Pathological fractures
- The patients who don't want to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End FracturesAlso: Titanium Alloy Plate surgery, Carbon Alloy Plate surgerySurgery 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 | Procedure or surgery | Titanium Alloy Plates Group, Volar Carbon Plate Effects on Procedure Time |
Primary outcome
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.
Radiation Exposure
Time frame: 0-1 hours of the surgery
Time elapsed in minutes during the surgery
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Volar Carbon Plate Applications on Radiation Exposure and Procedure Time in Intra-articular Radius Distal End Fractures in people with Radiation Exposure and Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedures Time (time frame: 0-1 hours of the surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.