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.
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.
Finland1 site, 1 recruiting
- Recruiting
Tampere University hospital
Tampere, 33521
Piia Suomalainen
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
- Conditions
- Acetabulum Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Endoscopic assisted acetabulum fractrure treatment | Active comparator | Not described Receives: Procedure: Endoscopy assisted |
| Open reduction | Active comparator | Not described Receives: Procedure: Endoscopy assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major complications
Measured: At three months
Number of patients with minor complications
Measured: At three months
Operation time
Measured: Intraoperative
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.
- First posted15 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabulum FractureStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Endoscopic Surgical Technique of the Acetabulum: A Minimally Invasive Operative Technique for the Extraperitoneal Fixation of Acetabulum Fractures
- ClinicalTrials.gov ID
- NCT06365112
- Acronym / sponsor ID
- R21154
- Conditions
- Acetabulum Fracture
- Keywords
- acetabulum fracture, Endoscopy, Minimal invasive, collaboration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Apr 2024 (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.
Try to develop an endoscopic surgical technique to treat acetabulum fractures
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic assisted acetabulum fractrure treatment | Active comparator | Procedure: Endoscopy assisted |
| Open reduction | Active comparator | Procedure: Endoscopy assisted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acetabulum fracture
Key exclusion criteria (2 listed)
- <18years
- Previous lower abdominal operation
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 |
|---|---|---|
| Endoscopy assistedEndoscopy | Procedure or surgery | Endoscopic assisted acetabulum fractrure treatment, Open reduction |
Primary outcome
Number of patients with major complications
Time frame: At three months
Number of patients with minor complications
Time frame: At three months
Operation time
Time frame: Intraoperative
Patient satisfaction using EQ5D
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Pelvic and Acetabular Fracture: A Prospective Observational Study
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Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
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PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
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Functional and Radiological Outcomes of Pediatric Acetabular Fracture Management
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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.
1 site in 1 country: see every site and its status.
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.