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

NCT03460418 | Completed

• 1 other identifier: CHUB-Multiloc
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Humeral Fractures

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

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

Phone contact OTHER

Assessment of the different outcomes by means of a phone contact

Multiloc nail; Philos plate; arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Tamas Illes: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Victorien Gauchez

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 9, 2018
• Study Start: April 1, 2018
• Primary Completion: May 28, 2018
• Study Completion: May 28, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)