Pelvic Ring FractureNCT03952026
Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Injuries
An observational study of Pelvic Ring Fracture and Acetabular Fracture, run by BG Trauma Center Tuebingen at 1 site in Germany.
Trial summary
Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Ring Fracture, Acetabular Fracture, Abdominal Trauma
- What is being tested?
- osteosynthesis of the pelvis
- Type of treatment
- Surgery or procedure
- How many people
- 16,359 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2018to 10 May 2019
- How long will I take part?
- 15 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a pelvic fracture Group 1: isolated pelvic fracture Group 2: combined abdominal/pelvic injury
Who may be able to join
- Pelvic fracture
Who cannot join
- no agreement to participate in the registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Fractures - a Multicenter Study From the German Pelvic Registry
Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. The combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. Whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.
Read the detailed description
The German Pelvic Registry of the German Trauma Society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. Beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. Beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). The clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications.
The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet.
The investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003 - 2017. Demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).
- Being tested
- osteosynthesis of the pelvis
- Keywords
- Pelvic trauma, Pelvic ring fracture, Acetabular Fracture, Abdominal Trauma, Polytrauma, Reduction quality
- Medical subject headings
- Abdominal Injuries, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteosynthesis of the pelvisProcedure or surgery
Osteosynthetic Fixation of the pelvic fracture
| Study group | Role | What they receive |
|---|---|---|
| isolated pelvic fracture | Patients with an isolated pelvic fracture Receives: Procedure: osteosynthesis of the pelvis | |
| combined abodominal/pelvic injury | Patients with a combined injury of a pelvic fracture and an abdominal injury. Receives: Procedure: osteosynthesis of the pelvis |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Matta" Grading
Quality of the reduction of the pelvic fracture measured in mm residual step at the fracture's site. A residual step of 0-2mm is graded as an "anatomical reduction" (=Matta 1), a residual step of 2-3mm is graded as an "Imperfect reduction" (=Matta 2) and a residual step >3mm is graded as a "poor reduction" (=Matta 3).
Measured: through study completion, at least 1 year after inclusion
Overall morbidity
Rate of overall complications
Measured: through study completion, at least 1 year after inclusion
Secondary outcomes (3)
osteosynthesis-associated complications
Rate of osteosynthesis-associated complications
Measured: through study completion, at least 1 year after inclusion
length of hospital stay
Duration of the inpatient Treatment, measured in days.
Measured: through study completion, at least 1 year after inclusion
Time until definitive pelvic surgery
The time until the definitive surgical procedure for the pelvic fracture, measured in days.
Measured: through study completion, at least 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start6 Dec 2018
- Primary completion31 Dec 2018
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Ring 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,359 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Küper, BG Trauma Center Tuebingen
- Investigators
- Markus A Küper, MD, Principal investigator, BG Trauma Center Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952026
- Sponsor's protocol ID
- 001
- Status last verified
- May 2019
- First submitted
- 11 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kuper MA, Bachmann R, Wenig GF, Ziegler P, Trulson A, Trulson IM, Minarski C, Ladurner R, Stockle U, Hoch A, Herath SC, Stuby FM; Working Group on Pelvic Fractures of the German Trauma Society. Associated abdominal injuries do not influence quality of care in pelvic fractures-a multicenter cohort study from the German Pelvic Registry. World J Emerg Surg. 2020 Jan 17;15:8. doi: 10.1186/s13017-020-0290-x. eCollection 2020.
PubMed 31988652
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Fractures - a Multicenter Study From the German Pelvic Registry
- ClinicalTrials.gov ID
- NCT03952026
- Acronym / sponsor ID
- 001
- Keywords
- Pelvic trauma, Pelvic ring fracture, Acetabular Fracture, Abdominal Trauma, Polytrauma, Reduction quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,359 participants (actual)
- Lead sponsor
- BG Trauma Center TuebingenUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 16 May 2019 (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.
Pelvic fractures are severe injuries which require advanced orthopedic surgical skills to treat. On the other hand, abdominal injuries are severe injuries, which might require quick general surgical treatment. The combination of both injuries is a challenge for orthopedic surgeons, as the abdominal injury might lead to a delayed surgical treatment of the pelvic fracture. Whether an associated abdominal injury influences the quality of care of pelvic fractures, is aim of this registry study.
Detailed description
The German Pelvic Registry of the German Trauma Society is a multicenter prospective registry which collects data of patients with pelvic injuries since 2003. Beside demographic data (including concomitant injuries) allowing for epidemiological evaluations of the development of surgical care in these patients, namely the operative care is focus of this registry. Beside the chosen procedure or surgical approach, this includes both intraoperative data like time until operation, duration of the procedure or intraoperative blood loss and reduction parameters (pre- and postoperative fracture steps). The clinical course is recorded also including overall morbidity, overall mortality and osteosynthesis-related complications.
The influence of a concomitant abdominal trauma on the quality of care regarding operative parameters like reduction quality or the clinical course in pelvic injuries has not been investigated yet.
The investigators therefore retrospectively analyze the prospective consecutive data of patients from the multicenter German Pelvic Registry of the German Trauma Society in the years 2003 - 2017. Demographic, clinical and operative parameter were recorded and compared in two groups (isolated pelvic fracture vs. combined abdominal/pelvic trauma).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated pelvic fracture | – | Procedure: osteosynthesis of the pelvisPatients with an isolated pelvic fracture |
| combined abodominal/pelvic injury | – | Procedure: osteosynthesis of the pelvisPatients with a combined injury of a pelvic fracture and an abdominal injury. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a pelvic fracture Group 1: isolated pelvic fracture Group 2: combined abdominal/pelvic injury
Key inclusion criteria (1 listed)
- Pelvic fracture
Key exclusion criteria (1 listed)
- no agreement to participate in the registry
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 |
|---|---|---|
| osteosynthesis of the pelvisOsteosynthetic Fixation of the pelvic fracture | Procedure or surgery | combined abodominal/pelvic injury, isolated pelvic fracture |
Primary outcome
"Matta" Grading
Time frame: through study completion, at least 1 year after inclusion
Quality of the reduction of the pelvic fracture measured in mm residual step at the fracture's site. A residual step of 0-2mm is graded as an "anatomical reduction" (=Matta 1), a residual step of 2-3mm is graded as an "Imperfect reduction" (=Matta 2) and a residual step >3mm is graded as a "poor reduction" (=Matta 3).
Overall morbidity
Time frame: through study completion, at least 1 year after inclusion
Rate of overall complications
3 secondary outcomes
osteosynthesis-associated complications
Time frame: through study completion, at least 1 year after inclusion
length of hospital stay
Time frame: through study completion, at least 1 year after inclusion
Time until definitive pelvic surgery
Time frame: through study completion, at least 1 year after inclusion
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 16 May 2019.
- Derived from this study: PubMed 31988652Kuper MA, Bachmann R, Wenig GF, Ziegler P, Trulson A, Trulson IM, Minarski C, Ladurner R, Stockle U, Hoch A, Herath SC, Stuby FM; Working Group on Pelvic Fractures of the German Trauma Society. Associated abdominal injuries do not influence quality of care in pelvic fractures-a multicenter cohort study from the German Pelvic Registry. World J Emerg Surg. 2020 Jan 17;15:8. doi: 10.1186/s13017-020-0290-x. eCollection 2020.
- Individual participant dataSharing planned: Yes
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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.
Markus A Küper, MD principal investigator
BG Trauma Center Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Ring Fracture and Acetabular Fracture, run by BG Trauma Center Tuebingen at 1 site in Germany.
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 1 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 16 May 2019. 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 Germany. 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?
"Matta" Grading (time frame: through study completion, at least 1 year after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952026, which also lists 1 linked publication.
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 16 May 2019.