Olecranon FractureNCT06615999
Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon
An observational study of Olecranon Fracture, run by University Hospital Muenster.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olecranon Fracture
- What is being tested?
- Simple fracture Tension band wiring, Simple fracture locked plate fixation and Multi-fragmented tension band wiring
- Type of treatment
- Surgery or procedure
- How many people
- 15,705 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Inpatient coded diagnosis of olecranon fracture (ICD S52.01)
Who cannot join
- 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
About this study
Official title: Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon - Analysis of Complications, Risk Profiles and Trends
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
- Being tested
- Simple fracture Tension band wiring, Simple fracture locked plate fixation, Multi-fragmented tension band wiring, Multi-fragmented locked plate fixation
- Keywords
- Olecranon fracture, surgical treatment, locked plate fixation, tension band wiring
- Medical subject headings
- Olecranon Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple fracture Tension band wiringProcedure or surgery
OPS 5-793.27
Simple fracture locked plate fixationProcedure or surgery
OPS 5-793.k7
Multi-fragmented tension band wiringProcedure or surgery
OPS 5-794.17
Multi-fragmented locked plate fixationProcedure or surgery
OPS 5-794.k7
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Multi-fragmented tension band wiring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision
Time from surgery to revision defined above.
Measured: 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
Measured: 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.
Measured: up to 5 years
In-hospital surgical complication rate (IH-SC)
surgical complication after surgery during index hospitalization (yes/no)
Measured: 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
Measured: 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
Measured: through hospital stay, an average of 10 days
Secondary outcomes (7)
Overall survival (OS)
- 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.
Measured: up to 5 years
30-day mortality
- Death from any cause within first day after surgery (yes/no)
- All patients with shorter follow-up time are excluded
Measured: 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.
Measured: up to 5 years
Thromboembolic events
Time from surgery to a thromboembolic event or death of any cause.
Measured: up to five years
Minor outpatient complication
Time from discharge to minor outpatient complications, with death being considered as a competing risk event.
Measured: up to five years
Length of hospital stay during index
Days of hospitalization (from admission to last discharge with index case series)
Measured: an average of 10 days
Charges during index
Sum of charges of all cases of the index case series
Measured: an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2011
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olecranon FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Münster
- Responsible party
- Principal investigator, Prof. Dr. med. J. Christoph Katthagen, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615999
- Sponsor's protocol ID
- Olecranon TBW vs. LPF
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Reality of Tension Band Wiring and Locked Plate Fixation of the Olecranon - Analysis of Complications, Risk Profiles and Trends
- ClinicalTrials.gov ID
- NCT06615999
- Acronym / sponsor ID
- Olecranon TBW vs. LPF
- Conditions
- Olecranon Fracture
- Keywords
- Olecranon fracture, surgical treatment, locked plate fixation, tension band wiring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,705 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Universität Münster
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Locking Plate fixation for simple fractured OFs (sLPF) | – | Procedure: Simple fracture locked plate fixationPatients 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) | – | Procedure: Multi-fragmented locked plate fixationPatients 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) | – | Procedure: Simple fracture Tension band wiringPatients 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) | – | Procedure: Multi-fragmented tension band wiringPatients allocated to this treatment group received a tension band wiring fixation after the first coded diagnosis of multi-fragmented OF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Inpatient coded diagnosis of olecranon fracture (ICD S52.01)
Key exclusion criteria (8 listed)
- Incomplete basic information
- Incomplete insurance status within two years before index
- Previous treatment of olecranon fracture
- Unclear treatment of olecranon fracture
- Age \< 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple fracture Tension band wiringOPS 5-793.27 | Procedure or surgery | Tension band wiring for simple fractured OFs (sTBW) |
| Simple fracture locked plate fixationOPS 5-793.k7 | Procedure or surgery | Locking Plate fixation for simple fractured OFs (sLPF) |
| Multi-fragmented tension band wiringOPS 5-794.17 | Procedure or surgery | Tension band wiring for multi-fragmented OFs (TBW) |
| Multi-fragmented locked plate fixationOPS 5-794.k7 | Procedure or surgery | Locking Plate fixation for multi-fragmented OFs (LPF) |
Primary outcome
Revision
Time frame: up to 5 years
Time from surgery to revision defined above.
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
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.
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)
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
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
7 secondary outcomes
Overall survival (OS)
Time frame: up to 5 years
30-day mortality
Time frame: 30 days
Major adverse events (MAE)
Time frame: up to 5 years
Thromboembolic events
Time frame: up to five years
Minor outpatient complication
Time frame: up to five years
Length of hospital stay during index
Time frame: an average of 10 days
Charges during index
Time frame: an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Olecranon Fracture, run by University Hospital Muenster.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision (time frame: up to 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.