NCT06537024|Completed
Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
ReplPHF
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ReplPHF
Sponsor study identifier
observational
32,953
0 countries
N/A
Study Start
January 1, 2011
Actual (reported)Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2011
Actual (reported)September 30, 2022
Actual (reported)December 31, 2022
Actual (reported)July 3, 2024
Actual (reported)August 5, 2024
Actual (reported)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
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
patients treated with locked plate fixation
reverse total shoulder arthroplasty
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Koeppe J, Fischhuber K, Stolberg-Stolberg J, Marschall U, Raschke MJ, Faldum A, Katthagen JC. The replicability of real-world evidence for the surgical treatment of proximal humeral fractures in older patients evaluated using sceptical p-value. Sci Rep. 2026 Sep 8;16(1):28068. doi: 10.1038/s41598-026-70157-6.
32,953 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2024
First Posted
August 5, 2024
Study Start
January 1, 2011
Actual (reported)Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
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Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
August 5, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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