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

Completed

• Conditions: Olecranon Fracture
• Interventions: Procedure: Multi-fragmented locked plate fixation; Procedure: Simple fracture Tension band wiring; Procedure: Multi-fragmented tension band wiring; Procedure: Simple fracture locked plate fixation

• Registration Number: NCT06615999
• Lead Sponsor: University Hospital Muenster

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\'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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15705

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Locking Plate fixation for multi-fragmented OFs (LPF)	Multi-fragmented locked plate fixation	Patients allocated to this treatment group received a locking plate fixation after after the first coded diagnosis of multi-fragmented OF.
Tension band wiring for simple fractured OFs (sTBW)	Simple fracture Tension band wiring	Patients allocated to this treatment group received a tension band wiring fixation after the first coded diagnosis of simple fractured OF.
Tension band wiring for multi-fragmented OFs (TBW)	Multi-fragmented tension band wiring	Patients allocated to this treatment group received a tension band wiring fixation after the first coded diagnosis of multi-fragmented OF.
Locking Plate fixation for simple fractured OFs (sLPF)	Simple fracture locked plate fixation	Patients allocated to this treatment group received a locking plate fixation after the first coded diagnosis of simple fractured OF.

Primary Outcome Measures

Name	Time	Method
Revision	up to 5 years	Time from surgery to revision defined above.
Implant removal (only)	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
Surgical complications (surgical complications)	up to 5 years	Time from surgery of olecranon fracture to surgical complications, with death being considered as a competing risk event.
In-hospital surgical complication rate (IH-SC)	through hospital stay, an average of 10 days	surgical complication after surgery during index hospitalization (yes/no)
In-hospital implant-associated complications (IH-IAC)	through hospital stay, an average of 10 days	In-hospital implant-associated complications after surgery during index hospitalization
In-hospital non-implant associated complications (IH-non-IAC)	through hospital stay, an average of 10 days	Non-in-hospital implant-associated complications after surgery during index hospitalizationi

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	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.
30-day mortality	30 days	* Death from any cause within first day after surgery (yes/no); * All patients with shorter follow-up time are excluded
Major adverse events (MAE)	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.
Thromboembolic events	up to five years	Time from surgery to a thromboembolic event or death of any cause.
Minor outpatient complication	up to five years	Time from discharge to minor outpatient complications, with death being considered as a competing risk event.
Length of hospital stay during index	an average of 10 days	Days of hospitalization (from admission to last discharge with index case series)
Charges during index	an average of 10 days	Sum of charges of all cases of the index case series