Pelvis; FractureAO TOPNCT06550934
Surgical Treatment of Pelvis in Fragility Fracture in Germany: a Prospective, National, Multicenter, Observational, Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization
An observational study of Pelvis; Fracture, run by AO Innovation Translation Center.
Trial summary
Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pelvis; Fracture
- What is being tested?
- Fracture stabilization
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Oct 2027
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients 65 years or older with a fragility fracture in the pelvis.
Who may be able to join
- Patients with sacral FFP (no concomitant injuries) Types: IIc, IIIc, IVb, IVc according to Rommens and Hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included)
- Diagnostic workup for fracture diagnosis and classification performed using CT scan as per standard of care
- Indication for surgical fracture fixation as considered by the attending surgeon
- Age ≥ 65 yrs.
- Low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture
- ASA-Score ≤ 3 pts.
- Ability to provide informed consent according to the IRB/EC defined and approved procedures
Who cannot join
- Patients with multiple fractures
- Instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and/or fractures of the pubic rami next to the symphysis, that indicate instability
- Pelvic fractures due to high-energy trauma
- Pathologic fractures (eg, fractures caused by malignancy or infection)
- History of pelvic fracture or pelvic ring surgery (hip joint implants do not count)
- Clinically significant or unstable medical or surgical condition that prevents surgical treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.
Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.
- Conditions
- Pelvis; Fracture
- Being tested
- Fracture stabilization
- Keywords
- Pelvis, Fragility fracture, Classification, Management, Operative, Outcome
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture stabilizationProcedure or surgery
isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization
| Study group | Role | What they receive |
|---|---|---|
| Isolated posterior surgical fracture stabilization | Not described Receives: Procedure: Fracture stabilization | |
| Combined anterior-posterior surgical fracture stabilization | Not described Receives: Procedure: Fracture stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating
Perception of pain will be assessed using Numeric Rating Scale (NRS) from 1-10, where patient reports pain due to his/her pelvis fracture. A higher value correlates with greater pain.
Measured: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startMar 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis; 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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Collaborators
- AUC - Akademie der Unfallchirurgie, AO Trauma Deutschland e.V.
- Responsible party
- Sponsor
- Investigators
- Richard Stange, Prof, Principal investigator, Universitätsklinikum MünsterLars Grossterlinden, Prof, Principal investigator, Asklepios Klinik Altona, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550934
- Sponsor's protocol ID
- AO TOP
- Acronym
- AO TOP
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Pelvis in Fragility Fracture in Germany: a Prospective, National, Multicenter, Observational, Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization
- ClinicalTrials.gov ID
- NCT06550934
- Acronym / sponsor ID
- AO TOP / AO TOP
- Conditions
- Pelvis; Fracture
- Keywords
- Pelvis, Fragility fracture, Classification, Management, Operative, Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Collaborators
- AUC - Akademie der Unfallchirurgie, AO Trauma Deutschland e.V.
- Study start
- Mar 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 Aug 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.
Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.
Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated posterior surgical fracture stabilization | – | Procedure: Fracture stabilization |
| Combined anterior-posterior surgical fracture stabilization | – | Procedure: Fracture stabilization |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 65 years or older with a fragility fracture in the pelvis.
Key inclusion criteria (7 listed)
- Patients with sacral FFP (no concomitant injuries) Types: IIc, IIIc, IVb, IVc according to Rommens and Hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included)
- Diagnostic workup for fracture diagnosis and classification performed using CT scan as per standard of care
- Indication for surgical fracture fixation as considered by the attending surgeon
- Age ≥ 65 yrs.
- Low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture
Key exclusion criteria (6 listed)
- Patients with multiple fractures
- Instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and/or fractures of the pubic rami next to the symphysis, that indicate instability
- Pelvic fractures due to high-energy trauma
- Pathologic fractures (eg, fractures caused by malignancy or infection)
- History of pelvic fracture or pelvic ring surgery (hip joint implants do not count)
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 |
|---|---|---|
| Fracture stabilizationisolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization | Procedure or surgery | Combined anterior-posterior surgical fracture stabilization, Isolated posterior surgical fracture stabilization |
Primary outcome
Pain rating
Time frame: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis
Perception of pain will be assessed using Numeric Rating Scale (NRS) from 1-10, where patient reports pain due to his/her pelvis fracture. A higher value correlates with greater pain.
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Richard Stange, Prof principal investigator
Universitätsklinikum Münster
Lars Grossterlinden, Prof principal investigator
Asklepios Klinik Altona, Hamburg
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvis; Fracture, run by AO Innovation Translation Center.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Cynthia Sob, PhD (+41798937428, cynthia.sob@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating (time frame: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis). 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 14 Feb 2025.