Surgical Treatment of Pelvis in Fragility Fracture in Ger... | NCT06550934

Studies
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

NCT06550934

Sponsor

AO Innovation Translation Center

Status

Not yet recruiting

Last Update Posted

Feb 14, 2025Actual

Enrollment

420Estimated

Phase

Not provided

Conditions

Pelvis; Fracture

Interventions

Fracture stabilization

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Aug 9, 2024

First Submission Date that Met QC Criteria

Aug 9, 2024

First Posted Date

Aug 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2025

Last Update Posted Date

Feb 14, 2025Actual

Name	Class
AUC - Akademie der Unfallchirurgie	UNKNOWN
AO Trauma Deutschland e.V.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isolated posterior surgical fracture stabilization			Procedure: Fracture stabilization
Combined anterior-posterior surgical fracture stabilization			Procedure: Fracture stabilization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fracture stabilization	Procedure	isolated posterior surgical fracture stabilization vs. combined anterior-posterior surgical fracture stabilization	Combined anterior-posterior surgical fracture stabilization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Numeric Rating Scale (NRS) 3 month after surgical fixation of the fragility fracture of the pelvis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients 65 years or older with a fragility fracture in the pelvis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cynthia Sob, PhD	Contact	+41798937428		cynthia.sob@aofoundation.org

Overall Officials

Name	Affiliation	Role
Richard Stange, Prof	Universitätsklinikum Münster	Principal Investigator
Lars Grossterlinden, Prof	Asklepios Klinik Altona, Hamburg	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries