Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05630430 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
May 28, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
