Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06365112 |
| Other study ID # |
R21154 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
January 2028 |
Study information
| Verified date |
April 2024 |
| Source |
Tampere University Hospital |
| Contact |
Piia Suomalainen |
| Phone |
+3583311611 |
| Email |
piia.suomalainen[@]pirha.fi |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Try to develop an endoscopic surgical technique to treat acetabulum fractures
Description:
Endoscopically assisted acetabular fracture treatment
Introduction Acetabular fractures are uncommon trauma in Finnish population (1). The trauma
mechanism usually in elderly population is fall in same level and in younger population high
energy trauma such as motor vehicle accidents and fall from hights (1). Acetabular fractures
are classified according the Letournel classification in which the fractures are divided in
three main gategories: posterior column, both columns and anterior column (2).
These fractures are further divided into posterior column, posterior wall and posterior wall
plus posterior column fractures. These posterior only fractures are usually operated through
posterior approach. Both column fractures are further divided into six different types:
transverse, transverse plus posterior wall, both column, T-shaped (posterior column and
anterior hemitransverse), anterior column plus posterior hemitransverse; anterior wall plus
posterior hemitransverse. Anterior approach is used usually to these fractures sometimes
combined with posterior approach. The third fracture type is likewise divided into anterior
column, anterior wall and anterior wall plus anterior column fractures, which are usually
operated using anterior approach. (2)
Operative treatment is the golden standard in displaced high energy acetabulum fractures and
technique has traditionally been open reduction and internal fixation (ORIF). Approach, which
has been used to operate the anterior part of the acetabulum fractures, has been modified
Stoppa in which the acetabulum is exposed through low midline incision in extraperitoneal
region (3).
The problem with this approach is the visualization of the highest proportion of the pelvic
brim and usually fractures highest point, because of the anatomical reasons, peritoneum and
the arteria and vena femoralis goes nearby and sometimes prevent making the approach,
reduction and plating of the fracture safely. Some patients have also post operative problems
with the incision, they have pain in the anterior part of the pelvis. Also the dissection and
sometimes detachment of the rectus abdominis muscles may cause serious problems post
operatively.
Because of the problems with the approach, we have developed a novel technique in which we
make the visibility with endoscopic technique. Extraperitoneal endoscopy is used commonly in
the hernia reparation surgery nowadays (TEP). The acetabular fracture surgery is done in the
same area as the hernia surgery so the approach itself is not a new method but the idea that
fracture can be treated solely through endoroscopy is.
There are few published case reports similar as our method. One of which is from China and
the technique was that they made endoscopic approacs and treated the fracture with 3D-printed
model of the patients pelvis and then bended the plate matching the patients pelvis (4). The
report is quite scarse and it lacks long term results altogether.
The other case report is from Germany and is otherwise similar as our technique, but they
used additional ilioinguinal lateral approach to reduce the fracture and to introduce the
plate. They state, that this method will be a standard procedure in future trauma management
(5).
The reason for this study is thus to develop a novel method to operate anterior acetabular
fractures endoscopically in cadavers and to test it in prospective matter in patients.
Aims of the study
- Develop a safe endoscopic surgical method to treat anterior acetabular fractures
- Test the method in patients prospectively
- To find out, if this novel method saves operation theatre time, blood loss, post
operative patient satisfaction and VAS
Materials and methods The first part of the study includes the endoscopically assisted
acetabular operation development in Tampere surgical education centre. The surgical method
will be published.
The second part of the study is done in the Tampere University Hospital orthopaedics and
traumatology ward. It consists of three (3) patients operated with this new method. In this
part of the study, the patients will not be randomized, but we include all consecutive
eligible patients. There will be at least one publication about this study part.
The third part of the study is done in randomized controlled study design in which the other
group will be operated with the new endoscopically assisted method and the other group with
the nowadays standard modified Stoppa approach. This study consist of ten (10) patients.
There will be at least one publication about this study part.
Inclusion criteria are: age over 18 and anterior acetabular fracture, which can be treated
with endoscopic method. Exclusion criteria are: age lower than 18 and previous lower abdomen
operation
