Proximal Humeral FractureNCT03464578
Evidence Based Algorithm for Proximal Humerus Fractures
An observational study of Proximal Humeral Fracture, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures. Objective(s): 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Therapy of proximal humeral fractures (irrespective conservative or operative)
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 31 Dec 2020
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with an acute proximal humeral fracture admitted to our institution.
Who may be able to join
- Acute traumatic proximal humeral fracture
- Signed informed consent
Who cannot join
- Fracture older than 48 hours at admission
- Multilevel fractures of the humerus
- Pathological fractures
- Terminally ill patients.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedic Surgery and Traumatology
Sankt Gallen, 9007
About this study
Official title: Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results
Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures.
Objective(s):
Read more
- Test the algorithm in terms of clinical applicability and clinical outcome
- Compare general outcome and general complication/revision rate to the literature.
Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.
Terminally ill patients and those not being able, or willing to sing the informed consent.
Project Centre(s): Single-centre.
Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.
Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Therapy of proximal humeral fractures (irrespective conservative or operative)
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy of proximal humeral fractures (irrespective conservative or operative)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Score
Point 0-100
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 143 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Jost, Cantonal Hospital of St. Gallen
- Investigators
- Bernhard Jost, MD, Study director, Head of the departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464578
- Sponsor's protocol ID
- ProxHumFx
- Status last verified
- Aug 2021
- First submitted
- 1 Mar 2018
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results
- ClinicalTrials.gov ID
- NCT03464578
- Acronym / sponsor ID
- ProxHumFx
- Conditions
- Proximal Humeral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Mar 2018 (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.
Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures.
Objective(s):
- Test the algorithm in terms of clinical applicability and clinical outcome
- Compare general outcome and general complication/revision rate to the literature.
Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.
Terminally ill patients and those not being able, or willing to sing the informed consent.
Project Centre(s): Single-centre.
Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.
Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with an acute proximal humeral fracture admitted to our institution.
Key inclusion criteria (2 listed)
- Acute traumatic proximal humeral fracture
- Signed informed consent
Key exclusion criteria (4 listed)
- Fracture older than 48 hours at admission
- Multilevel fractures of the humerus
- Pathological fractures
- Terminally ill patients.
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 |
|---|---|---|
| Therapy of proximal humeral fractures (irrespective conservative or operative) | Procedure or surgery | – |
Primary outcome
Constant Score
Time frame: One year
Point 0-100
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 16 Aug 2021.
- 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.
Bernhard Jost, MD study director
Head of the departement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fracture, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 2 inclusion and 4 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Constant Score (time frame: One year). 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 16 Aug 2021.