Humeral FracturesNCT03460418
Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
An observational study of Humeral Fractures, run by Tamas Illes at 1 site in Belgium.
Trial summary
Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone. Non- or little-displaced proximal humerus fractures are treated orthopedically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Phone contact
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2018to 28 May 2018
- 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 patients beeing treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Who may be able to join
- All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone.
Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.
This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.
- Conditions
- Humeral Fractures
- Being tested
- Phone contact
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone contactOther
Assessment of the different outcomes by means of a phone contact
| Study group | Role | What they receive |
|---|---|---|
| Multiloc nail | Fracture treated with a Multiloc nail (patients treated between 2012 and 2017) Receives: Other: Phone contact | |
| Philos plate | Fracture treated with a Philos plate (patients treated between 2012 and 2017) Receives: Other: Phone contact | |
| arthroplasty | Fracture treated by arthroplasty (patients treated between 2012 and 2017) Receives: Other: Phone contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture classification (AO)
Fracture classification according to the "Müller AO Classification of fractures - long bones"
Measured: one year
Fracture classification (NEER)
Fracture classification according to the "Neer classification of proximal humeral fractures"
Measured: one year
Dash score
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score is computed according to this formula: ([(sum of n responses)/n] -1)(25) where n represents the number of completed items. A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.The score ranges from 0 (no disability) to 100 (most severe disability).
Measured: one year
Constant score
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: one year
QoL 36
The QoL 36 quality of life questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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 posted9 Mar 2018
- Study start1 Apr 2018
- Primary completion28 May 2018
- Study completion28 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamas Illes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamas Illes, Brugmann University Hospital
- Investigators
- Victorien Gauchez, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460418
- Sponsor's protocol ID
- CHUB-Multiloc
- Status last verified
- May 2018
- First submitted
- 5 Mar 2018
- Last updated
- 30 May 2018
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
- ClinicalTrials.gov ID
- NCT03460418
- Acronym / sponsor ID
- CHUB-Multiloc
- Conditions
- Humeral Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tamas IllesUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 9 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 more common in older people. They can be caused by a minor trauma on an osteoporotic bone.
Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.
This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiloc nail | – | Other: Phone contactFracture treated with a Multiloc nail (patients treated between 2012 and 2017) |
| Philos plate | – | Other: Phone contactFracture treated with a Philos plate (patients treated between 2012 and 2017) |
| arthroplasty | – | Other: Phone contactFracture treated by arthroplasty (patients treated between 2012 and 2017) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients beeing treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Key inclusion criteria (1 listed)
- All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Phone contactAssessment of the different outcomes by means of a phone contact | Other | Multiloc nail, Philos plate, arthroplasty |
Primary outcome
Fracture classification (AO)
Time frame: one year
Fracture classification according to the "Müller AO Classification of fractures - long bones"
Fracture classification (NEER)
Time frame: one year
Fracture classification according to the "Neer classification of proximal humeral fractures"
Dash score
Time frame: one year
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score is computed according to this formula: ([(sum of n responses)/n] -1)(25) where n represents the number of completed items. A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.The score ranges from 0 (no disability) to 100 (most severe disability).
Constant score
Time frame: one year
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
QoL 36
Time frame: one year
The QoL 36 quality of life questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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 30 May 2018.
- Individual participant dataSharing planned: No
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Study on Outcomes of Proximal Humerus Fractures
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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.
Victorien Gauchez principal investigator
CHU Brugmann
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 Tamas Illes at 1 site in Belgium.
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 1 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 30 May 2018. 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 Belgium. 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?
Fracture classification (AO) (time frame: one year). The study lists 5 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 30 May 2018.