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Completed

NCT Number: NCT06537024

Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture

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.

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Key information

Conditions

Proximal Humeral Fracture Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

see Protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTSA

Procedure

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days

    Death from any cause during the first 30-days after surgery.

  2. Overall survival (OS)

    Time frame: up to 12 years

    Time from discharge of index hospitalization to death of any case.

  3. Major adverse events during index case

    Time frame: through hospital stay, an average of 16 days

    See above, only events during hospitalization

  4. Major adverse events after discharge

    Time frame: up to 12 years

    Time from discharge of index hospitalization to MAE as defined above

  5. Thromboembolic events during index

    Time frame: through hospital stay, an average of 16 days

    See above, only events during hospitalization

  6. Thromboembolic events (or death) after discharge

    Time frame: up to 12 years

    Time from discharge of index hospitalization to a thromboembolic event or death of any case.

  7. Surgical complications during index case

    Time frame: through hospital stay, an average of 16 days

    See above, only events during hospitalization

  8. Surgical complications after discharge

    Time frame: up to 12 years

    Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.

Secondary outcomes

  1. Implant-associated complication during index

    Time frame: through hospital stay, an average of 16 days

    See above, only events during hospitalization

  2. Non-Implant-associated complication during index

    Time frame: through hospital stay, an average of 16 days

    See above, only events during hospitalization

  3. Minor outpatient complications after discharge

    Time frame: up to 12 years

    Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event.

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Universität Münster

Registry information

Acronym: ReplPHF

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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