Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

NCT06537024 | Completed

• 1 other identifier: Replication PHF
• Study Type: observational
• Target: 32,953
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Proximal Humeral Fracture

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• 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

Study Arms (2)

LPF

patients treated with locked plate fixation

RTSA

reverse total shoulder arthroplasty

Procedure: RTSA

Interventions

RTSA PROCEDURE

RTSA

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• \- all patients will be included, who had an inpatient coded treatment using LPF or RTSA

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Universität Münster: collaborator

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 5, 2024
• Study Start: January 1, 2011
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share