Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550934
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Surgical Treatment of Pelvis in Fragility Fracture in Germany TOP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Surgical Treatment of Pelvis in Fragility Fracture in Germany a National Multicenter Observational Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOP
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None