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

NCT06615999 | Completed

• 1 other identifier: Olecranon TBW vs. LPF
• Study Type: observational
• Target: 15,705
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Olecranon Fracture

Keywords

Olecranon fracture; surgical treatment; locked plate fixation; tension band wiring

Outcome Measures

Primary Outcomes (6)

• Revision

  Time from surgery to revision defined above.

  up to 5 years

• Implant removal (only)

  * 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

  up to 5 years

• Surgical complications (surgical complications)

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

  up to 5 years

• In-hospital surgical complication rate (IH-SC)

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

  through hospital stay, an average of 10 days

• In-hospital implant-associated complications (IH-IAC)

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

  through hospital stay, an average of 10 days

• In-hospital non-implant associated complications (IH-non-IAC)

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

  through hospital stay, an average of 10 days

Secondary Outcomes (7)

• Overall survival (OS)

  up to 5 years

• 30-day mortality

  30 days

• Major adverse events (MAE)

  up to 5 years

• Thromboembolic events

  up to five years

• Minor outpatient complication

  up to five years

Study Arms (4)

Locking Plate fixation for simple fractured OFs (sLPF)

Patients allocated to this treatment group received a locking plate fixation after the first coded diagnosis of simple fractured OF.

Procedure: Simple fracture locked plate fixation

Locking Plate fixation for multi-fragmented OFs (LPF)

Patients allocated to this treatment group received a locking plate fixation after after the first coded diagnosis of multi-fragmented OF.

Procedure: Multi-fragmented locked plate fixation

Tension band wiring for simple fractured OFs (sTBW)

Patients allocated to this treatment group received a tension band wiring fixation after the first coded diagnosis of simple fractured OF.

Procedure: Simple fracture Tension band wiring

Tension band wiring for multi-fragmented OFs (TBW)

Patients allocated to this treatment group received a tension band wiring fixation after the first coded diagnosis of multi-fragmented OF.

Procedure: Multi-fragmented tension band wiring

Interventions

Simple fracture Tension band wiring PROCEDURE

OPS 5-793.27

Tension band wiring for simple fractured OFs (sTBW)

Simple fracture locked plate fixation PROCEDURE

OPS 5-793.k7

Locking Plate fixation for simple fractured OFs (sLPF)

Multi-fragmented tension band wiring PROCEDURE

OPS 5-794.17

Tension band wiring for multi-fragmented OFs (TBW)

Multi-fragmented locked plate fixation PROCEDURE

OPS 5-794.k7

Locking Plate fixation for multi-fragmented OFs (LPF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 (\<70 years) and older patients (≥ 70 years) will be analyzed in separate studies.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Universität Münster: collaborator

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Ulna Fractures; Forearm Injuries; Fractures, Bone

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: September 17, 2024
• First Posted: September 27, 2024
• Study Start: January 1, 2011
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share