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

Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460418
• Other study ID #: CHUB-Multiloc
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 28, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 28, 2018
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

Other:
• Phone contact
Assessment of the different outcomes by means of a phone contact

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Tamas Illes

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture classification (AO)	Fracture classification according to the "Müller AO Classification of fractures - long bones"	one year
Primary	Fracture classification (NEER)	Fracture classification according to the "Neer classification of proximal humeral fractures"	one year
Primary	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
Primary	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
Primary	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