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

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 Overview

• Status: Completed
• Conditions: Humeral Fractures
• Intervention / Treatment: Other: Phone contact

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiloc nail; Fracture treated with a Multiloc nail (patients treated between 2012 and 2017)	Other: Phone contact; Assessment of the different outcomes by means of a phone contact
Philos plate; Fracture treated with a Philos plate (patients treated between 2012 and 2017)	Other: Phone contact; Assessment of the different outcomes by means of a phone contact
arthroplasty; Fracture treated by arthroplasty (patients treated between 2012 and 2017)	Other: Phone contact; Assessment of the different outcomes by means of a phone contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture classification (AO)	Fracture classification according to the "Müller AO Classification of fractures - long bones"	one year
Fracture classification (NEER)	Fracture classification according to the "Neer classification of proximal humeral fractures"	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).	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.	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.	one year

Collaborators and Investigators

• Sponsor: Tamas Illes
• Investigators: Principal Investigator: Victorien Gauchez, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): May 28, 2018
• Study Completion (Actual): May 28, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: CHUB-Multiloc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No