Clinical trial NCT06550934: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pelvis; Fracture
Keywords: Pelvis
Fragility fracture
Classification
Management
Operative
Outcome
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AUC - Akademie der Unfallchirurgie
name: AO Trauma Deutschland
First posted: 2024-08-13
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 65 years or older with a fragility fracture in the pelvis.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain rating
timeFrame: Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Münster
name: Richard Stange, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Asklepios Klinik Altona, Hamburg
name: Lars Grossterlinden, Prof
role: PRINCIPAL_INVESTIGATOR
References: