Proximal Humeral FractureReplPHFNCT06537024
Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
An observational study of Proximal Humeral Fracture, run by University Hospital Muenster.
Trial summary
The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- RTSA
- Type of treatment
- Surgery or procedure
- How many people
- 32,953 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients were grouped into two treatment groups: LPF (reference group) or RTSA depending on which therapy was performed first. If RTSA and LPF were coded at the same day, patients were assigned to RTSA group. Two different analysis sets were defined as follows: * Short-term set: including all patients. * Long-term set: including all patients, which were discharged alive and had an index surgery before 2022 (to guarantee a possible follow-up time of a least one year).
Who may be able to join
- all patients will be included, who had an inpatient coded treatment using LPF or RTSA
Who cannot join
- Incomplete insurance status within two years before index
- Incomplete basic information
- Age<65 years
- Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
- Previous surgical treatment (RTSA, LPF or other fracture fixation)
- Coded polytrauma
Show all 9Show fewer
- Bone tumors/ bone metastasis
- Both sides or missing information of surgery side
- COVID-19 infection during index hospitalization
About this study
The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
Read the detailed description
see Protocol
- Conditions
- Proximal Humeral Fracture
- Being tested
- RTSA
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTSAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LPF | patients treated with locked plate fixation | |
| RTSA | reverse total shoulder arthroplasty Receives: Procedure: RTSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Death from any cause during the first 30-days after surgery.
Measured: 30 days
Overall survival (OS)
Time from discharge of index hospitalization to death of any case.
Measured: up to 12 years
Major adverse events during index case
See above, only events during hospitalization
Measured: through hospital stay, an average of 16 days
Major adverse events after discharge
Time from discharge of index hospitalization to MAE as defined above
Measured: up to 12 years
Thromboembolic events during index
See above, only events during hospitalization
Measured: through hospital stay, an average of 16 days
Thromboembolic events (or death) after discharge
Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Measured: up to 12 years
Surgical complications during index case
See above, only events during hospitalization
Measured: through hospital stay, an average of 16 days
Surgical complications after discharge
Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
Measured: up to 12 years
Secondary outcomes (3)
Implant-associated complication during index
See above, only events during hospitalization
Measured: through hospital stay, an average of 16 days
Non-Implant-associated complication during index
See above, only events during hospitalization
Measured: through hospital stay, an average of 16 days
Minor outpatient complications after discharge
Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event.
Measured: up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2011
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral 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
- 32,953 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
- NCT06537024
- Sponsor's protocol ID
- Replication PHF
- Acronym
- ReplPHF
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koeppe J, Fischhuber K, Stolberg-Stolberg J, Marschall U, Raschke MJ, Faldum A, Katthagen JC. The replicability of real-world evidence for the surgical treatment of proximal humeral fractures in older patients evaluated using sceptical p-value. Sci Rep. 2026 Sep 8;16(1):28068. doi: 10.1038/s41598-026-70157-6.
PubMed 42711453
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication Study to Analyze the Surgical Treatment of Proximal Humeral Fracture
- ClinicalTrials.gov ID
- NCT06537024
- Acronym / sponsor ID
- ReplPHF / Replication PHF
- Conditions
- Proximal Humeral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,953 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Universität Münster
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Aug 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 study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
Detailed description
see Protocol
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPF | – | –patients treated with locked plate fixation |
| RTSA | – | Procedure: RTSAreverse total shoulder arthroplasty |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were grouped into two treatment groups: LPF (reference group) or RTSA depending on which therapy was performed first. If RTSA and LPF were coded at the same day, patients were assigned to RTSA group. Two different analysis sets were defined as follows: * Short-term set: including all patients. * Long-term set: including all patients, which were discharged alive and had an index surgery before 2022 (to guarantee a possible follow-up time of a least one year).
Key inclusion criteria (1 listed)
- all patients will be included, who had an inpatient coded treatment using LPF or RTSA
Key exclusion criteria (9 listed)
- Incomplete insurance status within two years before index
- Incomplete basic information
- Age<65 years
- Missing diagnosis of PHF (ICD: S42.2) within two years before surgery
- Previous surgical treatment (RTSA, LPF or other fracture fixation)
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 |
|---|---|---|
| RTSA | Procedure or surgery | RTSA |
Primary outcome
30-day mortality
Time frame: 30 days
Death from any cause during the first 30-days after surgery.
Overall survival (OS)
Time frame: up to 12 years
Time from discharge of index hospitalization to death of any case.
Major adverse events during index case
Time frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
Major adverse events after discharge
Time frame: up to 12 years
Time from discharge of index hospitalization to MAE as defined above
Thromboembolic events during index
Time frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
Thromboembolic events (or death) after discharge
Time frame: up to 12 years
Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Surgical complications during index case
Time frame: through hospital stay, an average of 16 days
See above, only events during hospitalization
Surgical complications after discharge
Time frame: up to 12 years
Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
3 secondary outcomes
Implant-associated complication during index
Time frame: through hospital stay, an average of 16 days
Non-Implant-associated complication during index
Time frame: through hospital stay, an average of 16 days
Minor outpatient complications after discharge
Time frame: up to 12 years
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 5 Aug 2024.
- Derived from this study: PubMed 42711453Koeppe J, Fischhuber K, Stolberg-Stolberg J, Marschall U, Raschke MJ, Faldum A, Katthagen JC. The replicability of real-world evidence for the surgical treatment of proximal humeral fractures in older patients evaluated using sceptical p-value. Sci Rep. 2026 Sep 8;16(1):28068. doi: 10.1038/s41598-026-70157-6.
- Individual participant dataSharing planned: No
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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 Proximal Humeral 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 9 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 5 Aug 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?
30-day mortality (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537024, which also lists 1 linked publication.
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 5 Aug 2024.