ClinicalTrials.gg
CompletedNCT03460418Updated May 30, 2018

Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.

An observational study in Humeral Fractures, sponsored by Tamas Illes. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-30.

Sponsored by Tamas Illes · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Humeral Fractures

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03

In context

Humeral Fractures

106 studies on the registry are indexed under Humeral Fractures; 20 are open to participants now.

This study's enrollment of 30 is below the median of 91 across 36 observational studies indexed under Humeral Fractures.

Browse Humeral Fractures studies →

Lead sponsor

Tamas Illes is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients beeing treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Multiloc nail

    Fracture treated with a Multiloc nail (patients treated between 2012 and 2017)

    Other: Phone contact

  • Philos plate

    Fracture treated with a Philos plate (patients treated between 2012 and 2017)

    Other: Phone contact

  • arthroplasty

    Fracture treated by arthroplasty (patients treated between 2012 and 2017)

    Other: Phone contact

Interventions

  • OtherPhone contact

    Assessment of the different outcomes by means of a phone contact

06

What researchers measure

Primary outcomes

  1. Fracture classification (AO)

    Fracture classification according to the "Müller AO Classification of fractures - long bones"

    Time frame: one year

  2. Fracture classification (NEER)

    Fracture classification according to the "Neer classification of proximal humeral fractures"

    Time frame: one year

  3. 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).

    Time frame: one year

  4. 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.

    Time frame: one year

  5. 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.

    Time frame: one year

07

Study locations

1 site
  • CHU Brugmann
    Brussels, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in May 2018, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 9, 2018
StartActual
Apr 1, 2018
Primary completionActual
May 28, 2018
CompletionActual
May 28, 2018
Last update
May 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03460418
Lead sponsor
Tamas Illes
Responsible party
Tamas Illes (Head of Clinic, Brugmann University Hospital) — Sponsor-investigator
First posted
Mar 9, 2018
Start date
Apr 1, 2018
Primary completion
May 28, 2018
Completion
May 28, 2018
Last update
May 30, 2018

Study contacts

Victorien Gauchez
principal investigator · CHU Brugmann

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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