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Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06537024
Acronym
ReplPHF
Enrollment
32953
Registered
2024-08-05
Start date
2011-01-01
Completion date
2022-12-31
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fracture

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

Interventions

PROCEDURERTSA

Sponsors

Universität Münster
CollaboratorOTHER
University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical complications after dischargeup to 12 yearsTime from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
Thromboembolic events during indexthrough hospital stay, an average of 16 daysSee above, only events during hospitalization
Thromboembolic events (or death) after dischargeup to 12 yearsTime from discharge of index hospitalization to a thromboembolic event or death of any case.
Surgical complications during index casethrough hospital stay, an average of 16 daysSee above, only events during hospitalization
30-day mortality30 daysDeath from any cause during the first 30-days after surgery.
Overall survival (OS)up to 12 yearsTime from discharge of index hospitalization to death of any case.
Major adverse events during index casethrough hospital stay, an average of 16 daysSee above, only events during hospitalization
Major adverse events after dischargeup to 12 yearsTime from discharge of index hospitalization to MAE as defined above

Secondary

MeasureTime frameDescription
Non-Implant-associated complication during indexthrough hospital stay, an average of 16 daysSee above, only events during hospitalization
Minor outpatient complications after dischargeup to 12 yearsTime from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event.
Implant-associated complication during indexthrough hospital stay, an average of 16 daysSee above, only events during hospitalization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026