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Completed

NCT Number: NCT06615999

Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon

The incidence of the olecranon fracture (OF) in adults is around 12 per 100,000 inhabitants per year.1 The anatomical shape of the proximal ulna is largely responsible for the stabilization of the humeroulnar joint and reconstruction is therefore obligatory, but often challenging. Surgical treatment of the olecranon fracture is performed using tension band wiring (TBW) or locking plate fixation (LPF) osteosynthesis. It is not yet clear, which procedure is superior for a specific patient. In future, an individualized and objectified assessment of expected general and fracture-specific complications should enable the treatment to be individually adapted to the patient's risk profile. This shall prevent complications, unnecessary treatments, and treatment costs. In the project presented here, the reality of care for surgically treated patients with olecranon fractures will be analyzed using routine data collected by the BARMER health insurance fund.

The aim of the study is to analyze differences in the outcome of patients with an olecranon fracture treated with TBW compared to LPF and to identify independent risk factors for unfavorable course.

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Key information

Conditions

Olecranon Fracture Arm Injuries Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Ulna Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inpatient coded diagnosis of olecranon fracture (ICD S52.01)

Exclusion criteria

  • Incomplete basic information
  • Incomplete insurance status within two years before index
  • Previous treatment of olecranon fracture
  • Unclear treatment of olecranon fracture
  • Age < 18 years
  • Coded polytrauma
  • Bone tumors/ bone metastasis
  • Both sides injured or missing information of surgery side

Treatment and study plan

Simple fracture Tension band wiring

Procedure

OPS 5-793.27

Simple fracture locked plate fixation

Procedure

OPS 5-793.k7

Multi-fragmented tension band wiring

Procedure

OPS 5-794.17

Multi-fragmented locked plate fixation

Procedure

OPS 5-794.k7

Primary outcomes

  1. Revision

    Time frame: up to 5 years

    Time from surgery to revision defined above.

  2. Implant removal (only)

    Time frame: up to 5 years

    • Time from surgery to implant removal
    • Within first 3 months after surgery, an implant removal will also considered as a surgical complication
    • No SC is allowed to occur within 3 months and on the same day

  3. Surgical complications (surgical complications)

    Time frame: up to 5 years

    Time from surgery of olecranon fracture to surgical complications, with death being considered as a competing risk event.

  4. In-hospital surgical complication rate (IH-SC)

    Time frame: through hospital stay, an average of 10 days

    surgical complication after surgery during index hospitalization (yes/no)

  5. In-hospital implant-associated complications (IH-IAC)

    Time frame: through hospital stay, an average of 10 days

    In-hospital implant-associated complications after surgery during index hospitalization

  6. In-hospital non-implant associated complications (IH-non-IAC)

    Time frame: through hospital stay, an average of 10 days

    Non-in-hospital implant-associated complications after surgery during index hospitalizationi

Secondary outcomes

  1. Overall survival (OS)

    Time frame: up to 5 years

    • Time from surgery to death of any cause.
    • Death will be determined using the coded death as the reason for withdrawal in the BARMER database. In addition, all inpatient cases will be reviewed during follow-up, to determine whether death was reported as the reason for discharge.

  2. 30-day mortality

    Time frame: 30 days

    • Death from any cause within first day after surgery (yes/no)
    • All patients with shorter follow-up time are excluded

  3. Major adverse events (MAE)

    Time frame: up to 5 years

    Time from surgery to resuscitation, cardiac arrest, myocardial infarction, stroke, acute renal failure, acute liver failure, acute respiratory distress syndrome, sepsis or death from any case.

  4. Thromboembolic events

    Time frame: up to five years

    Time from surgery to a thromboembolic event or death of any cause.

  5. Minor outpatient complication

    Time frame: up to five years

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

  6. Length of hospital stay during index

    Time frame: an average of 10 days

    Days of hospitalization (from admission to last discharge with index case series)

  7. Charges during index

    Time frame: an average of 10 days

    Sum of charges of all cases of the index case series

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Universität Münster

Registry information

Official study title

Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon - Analysis of Complications, Risk Profiles and Trends

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2024
Registry last updated
Sep 27, 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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