Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Proximal Humeral Fracture
- Sponsor
- University Hospital Muenster
- Enrollment
- 32953
- Primary Endpoint
- Surgical complications during index case
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
Detailed Description
see Protocol
Investigators
Prof. Dr. med. J. Christoph Katthagen
Senior Consultant
University Hospital Muenster
Eligibility Criteria
Inclusion Criteria
- •all patients will be included, who had an inpatient coded treatment using LPF or RTSA
Exclusion Criteria
- •Incomplete insurance status within two years before index
- •Incomplete basic information
- •Age\<65 years
- •Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
- •Previous surgical treatment (RTSA, LPF or other fracture fixation)
- •Coded polytrauma
- •Bone tumors/ bone metastasis
- •Both sides or missing information of surgery side
- •COVID-19 infection during index hospitalization
Outcomes
Primary Outcomes
Surgical complications during index case
Time Frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
30-day mortality
Time Frame: 30 days
Death from any cause during the first 30-days after surgery.
Overall survival (OS)
Time Frame: up to 12 years
Time from discharge of index hospitalization to death of any case.
Major adverse events during index case
Time Frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
Major adverse events after discharge
Time Frame: up to 12 years
Time from discharge of index hospitalization to MAE as defined above
Thromboembolic events during index
Time Frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
Thromboembolic events (or death) after discharge
Time Frame: up to 12 years
Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Surgical complications after discharge
Time Frame: up to 12 years
Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
Secondary Outcomes
- Implant-associated complication during index(through hospital stay, an average of 16 days)
- Non-Implant-associated complication during index(through hospital stay, an average of 16 days)
- Minor outpatient complications after discharge(up to 12 years)