Clinical trial NCT06615999: Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon
Official title: Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon - Analysis of Complications, Risk Profiles and Trends
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Olecranon Fracture
Keywords: Olecranon fracture
surgical treatment
locked plate fixation
tension band wiring
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Universität Münster
First posted: 2024-09-27
Enrollment: 15705
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with an age of 18 years and older with an inpatient treated OF (ICD S52.01) treated with LPF or TBW between 01/2011 and 09/2023 will be included to the evaluations. Patients were grouped by age (i.e. 18-44 years, 45 - 69 years, ≥ 70 years). Younger patients (\&lt;70 years) and older patients (≥ 70 years) will be analyzed in separate studies.

Brief summary: 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\&#39;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.


Eligibility criteria: 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 \&lt; 18 years
* Coded polytrauma
* Bone tumors/ bone metastasis
* Both sides injured or missing information of surgery side

Primary outcomes:
measure: Revision
timeFrame: up to 5 years
measure: Implant removal (only)
timeFrame: up to 5 years
measure: Surgical complications (surgical complications)
timeFrame: up to 5 years
measure: In-hospital surgical complication rate (IH-SC)
timeFrame: through hospital stay, an average of 10 days
measure: In-hospital implant-associated complications (IH-IAC)
timeFrame: through hospital stay, an average of 10 days
measure: In-hospital non-implant associated complications (IH-non-IAC)
timeFrame: through hospital stay, an average of 10 days
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 5 years
measure: 30-day mortality
timeFrame: 30 days
measure: Major adverse events (MAE)
timeFrame: up to 5 years
measure: Thromboembolic events
timeFrame: up to five years
measure: Minor outpatient complication
timeFrame: up to five years
measure: Length of hospital stay during index
timeFrame: an average of 10 days
measure: Charges during index
timeFrame: an average of 10 days
Other outcomes:
Locations:
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