Humeral Fracturesprox_humNCT02566018
Treatment of Proximal Humerus Fractures in the Elderly
An observational study of Humeral Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- treatment/medical device and standard
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2015to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Older adult
Study population: Patients fulfilling all of the following inclusion criteria
Who may be able to join
- Age of 65 years or above
- Proximal humerus fracture
- Informed consent by the patient or legal representatives to participate in the study
Who cannot join
- More than one fracture, polytrauma
- Suspicion of a pathological fracture in the context of known or unknown malignancy
- Previous surgery of the proximal humerus on the same side
- High energy trauma
- Open Fracture
- Insufficient German language skills
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4021
About this study
Official title: Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence
This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures
Read the detailed description
This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.
- Conditions
- Humeral Fractures
- Being tested
- treatment/medical device, standard
- Keywords
- elderly
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment/medical deviceProcedure or surgery
The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
standardProcedure or surgery
The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.
| Study group | Role | What they receive |
|---|---|---|
| experimental intervention | A greater degree of initial displacement is tolerated to allow for conservative, non-operative treatment in more simple fracture patterns. Two-part fractures with marked displacement including two part patterns with a non-displaced greater or minor tuberosity fracture (formally three part fractures) are treated with a proximal humerus nail; and displaced three and four part fractures are primarily managed with a reverse total shoulder arthroplasty. Proximal Humeral Internal Locking System (PHILOS)-plates are only used exceptionally in this group of patients. Receives: Procedure: treatment/medical device | |
| control intervention | Since May 2013 we have changed our treatment algorithm for the treatment of fractures of the humeral head in the elderly. Before this change in algorithm we used PHILOS plates extensively and rarely Inverse Shoulder prostheses.
In general all proximal humerus fractures were operated except minimally or undisplaced. Receives: Procedure: standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
personal dependency status
A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.
Measured: 6 months
Secondary outcomes (5)
range of motion
Measured: 6 months
Shoulder pain and disability index (SPADI)
The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available
Measured: 6 months
SSV
The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.
Measured: 6 months
General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)
The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.
Measured: 6 months
Quality of life (utilities) derived using EQ-5D-5L
Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start1 May 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rikli, Prof, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566018
- Sponsor's protocol ID
- 2014-310
- Acronym
- prox_hum
- Status last verified
- May 2024
- First submitted
- 30 Sep 2015
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.
PubMed 8970896Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 Jun;29(6):1127-1135. doi: 10.1016/j.jse.2019.11.006. Epub 2020 Feb 10.
PubMed 32057657
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence
- ClinicalTrials.gov ID
- NCT02566018
- Acronym / sponsor ID
- prox_hum / 2014-310
- Conditions
- Humeral Fractures
- Keywords
- elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures
Detailed description
This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental intervention | – | Procedure: treatment/medical deviceA greater degree of initial displacement is tolerated to allow for conservative, non-operative treatment in more simple fracture patterns. Two-part fractures with marked displacement including two part patterns with a non-displaced greater or minor tuberosity fracture (formally three part fractures) are treated with a proximal humerus nail; and displaced three and four part fractures are primarily managed with a reverse total shoulder arthroplasty. Proximal Humeral Internal Locking System (PHILOS)-plates are only used exceptionally in this group of patients. |
| control intervention | – | Procedure: standardSince May 2013 we have changed our treatment algorithm for the treatment of fractures of the humeral head in the elderly. Before this change in algorithm we used PHILOS plates extensively and rarely Inverse Shoulder prostheses. In general all proximal humerus fractures were operated except minimally or undisplaced. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients fulfilling all of the following inclusion criteria
Key inclusion criteria (3 listed)
- Age of 65 years or above
- Proximal humerus fracture
- Informed consent by the patient or legal representatives to participate in the study
Key exclusion criteria (6 listed)
- More than one fracture, polytrauma
- Suspicion of a pathological fracture in the context of known or unknown malignancy
- Previous surgery of the proximal humerus on the same side
- High energy trauma
- Open Fracture
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 |
|---|---|---|
| treatment/medical deviceThe new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards | Procedure or surgery | experimental intervention |
| standardThe old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013. | Procedure or surgery | control intervention |
Primary outcome
personal dependency status
Time frame: 6 months
A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.
5 secondary outcomes
range of motion
Time frame: 6 months
Shoulder pain and disability index (SPADI)
Time frame: 6 months
SSV
Time frame: 6 months
General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)
Time frame: 6 months
Quality of life (utilities) derived using EQ-5D-5L
Time frame: 6 months
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 14 May 2024.
- Results publication: PubMed 8970896Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.
- Results publication: PubMed 32057657Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 Jun;29(6):1127-1135. doi: 10.1016/j.jse.2019.11.006. Epub 2020 Feb 10.
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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.
Daniel Rikli, Prof principal investigator
University Hospital, Basel, Switzerland
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 Humeral Fractures, run by University Hospital, Basel, Switzerland 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 3 inclusion and 6 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 14 May 2024. 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?
personal dependency status (time frame: 6 months). 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 NCT02566018, which also lists 2 linked publications.
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 14 May 2024.