Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

Completed

• Conditions: Proximal Humeral Fracture
• Interventions: Procedure: RTSA

• Registration Number: NCT06537024
• Lead Sponsor: University Hospital Muenster

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

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32953

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RTSA	RTSA	reverse total shoulder arthroplasty

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	Death from any cause during the first 30-days after surgery.
Overall survival (OS)	up to 12 years	Time from discharge of index hospitalization to death of any case.
Major adverse events during index case	through hospital stay, an average of 16 days	See above, only events during hospitalization
Major adverse events after discharge	up to 12 years	Time from discharge of index hospitalization to MAE as defined above
Thromboembolic events during index	through hospital stay, an average of 16 days	See above, only events during hospitalization
Thromboembolic events (or death) after discharge	up to 12 years	Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Surgical complications during index case	through hospital stay, an average of 16 days	See above, only events during hospitalization
Surgical complications after discharge	up to 12 years	Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.

Secondary Outcome Measures

Name	Time	Method
Implant-associated complication during index	through hospital stay, an average of 16 days	See above, only events during hospitalization
Non-Implant-associated complication during index	through hospital stay, an average of 16 days	See above, only events during hospitalization
Minor outpatient complications after discharge	up to 12 years	Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event.