Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture (ReplPHF)

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Procedure: RTSA

Detailed Description

see Protocol

• Study Type: Observational
• Enrollment (Actual): 32953

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were grouped into two treatment groups: LPF (reference group) or RTSA depending on which therapy was performed first. If RTSA and LPF were coded at the same day, patients were assigned to RTSA group. Two different analysis sets were defined as follows:

• Short-term set: including all patients.
• Long-term set: including all patients, which were discharged alive and had an index surgery before 2022 (to guarantee a possible follow-up time of a least one year).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LPF; patients treated with locked plate fixation
RTSA; reverse total shoulder arthroplasty	Procedure: RTSA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Universität Münster

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: Replication PHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No