AzTrials
AzTrials

Acetabulum FractureEarly Phase 1NCT06365112

Endoscopic Acetabulum Surgery

A Early Phase 1 study testing Endoscopy assisted in people with Acetabulum Fracture, run by Tampere University Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Try to develop an endoscopic surgical technique to treat acetabulum fractures Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acetabulum Fracture
What is being tested?
Endoscopy assisted
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteFinland
Study dates
Apr 2024to Jan 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Acetabulum fracture

Who cannot join

  • <18years
  • Previous lower abdominal operation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Piia Suomalainen contact

+3583311611

piia.suomalainen@pirha.fi

Finland1 site, 1 recruiting
  • Tampere University hospital

    Tampere, 33521

    Piia Suomalainen

    Recruiting

Other trials in Finland

About this study

Official title: The Endoscopic Surgical Technique of the Acetabulum: A Minimally Invasive Operative Technique for the Extraperitoneal Fixation of Acetabulum Fractures

Try to develop an endoscopic surgical technique to treat acetabulum fractures

Read the detailed 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

Being tested
Endoscopy assisted
Keywords
acetabulum fracture, Endoscopy, Minimal invasive, collaboration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopy assistedProcedure or surgery

    Endoscopy

Study groups in NCT06365112
Study groupRoleWhat they receive
Endoscopic assisted acetabulum fractrure treatmentActive comparatorNot described
Receives: Procedure: Endoscopy assisted
Open reductionActive comparatorNot described
Receives: Procedure: Endoscopy assisted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with major complications

    Measured: At three months

  2. Number of patients with minor complications

    Measured: At three months

  3. Operation time

    Measured: Intraoperative

  4. Patient satisfaction using EQ5D

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365112
Sponsor's protocol ID
R21154
Status last verified
Apr 2024
First submitted
10 Apr 2024
Last updated
24 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Endoscopy assisted in people with Acetabulum Fracture, run by Tampere University Hospital at 1 site in Finland.

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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 Finland. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Piia Suomalainen (+3583311611, piia.suomalainen@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with major complications (time frame: At three months). The study lists 4 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 24 Apr 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in