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| Name | Class |
|---|---|
| Universität Münster | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple fracture Tension band wiring | Procedure | OPS 5-793.27 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision | Time from surgery to revision defined above. | up to 5 years |
| Implant removal (only) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) |
| up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
The authors confirm that the data utilized in this study cannot be made available in the manuscript, the supplemental files, or in a public repository due to German data protection laws ('Bundesdatenschutzgesetz', BDSG). They are stored on a server of the BARMER Institute for Health System Research, to facilitate replication of the results. In general, access to data of statutory health insurance funds for research purposes is possible only under the conditions defined in German Social Law (SGB V § 287).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2024 | Sep 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092470 | Olecranon Fracture |
| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
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| 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 |
|
| 30-day mortality |
|
| 30 days |
| Major adverse events (MAE) | 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. | up to 5 years |
| Thromboembolic events | Time from surgery to a thromboembolic event or death of any cause. | up to five years |
| Minor outpatient complication | Time from discharge to minor outpatient complications, with death being considered as a competing risk event. | up to five years |
| Length of hospital stay during index | Days of hospitalization (from admission to last discharge with index case series) | an average of 10 days |
| Charges during index | Sum of charges of all cases of the index case series | an average of 10 days |
| D014458 |
| Ulna Fractures |
| D005543 | Forearm Injuries |
| D050723 | Fractures, Bone |