Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus

Proximal Humeral Fractures Clinical Trial

Official title:

Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00835562
• Other study ID #: Shoulderfractures.RCT
• Secondary ID: H-C-2008-065
• Status: Recruiting
• Phase: Phase 3
• First received: February 2, 2009
• Last updated: June 6, 2012
• Start date: April 2009

Study information

• Verified date: June 2012
• Source: Herlev Hospital
• Contact: Stig Brorson, MD, PhD
• Email: sbrorson[@]hotmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.

The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.

The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Displaced four-part fracture of the proximal humerus

• Mentally alert

• Physically fit for surgery and rehabilitation (ASA-group 1-3)

• Informed written consent

• Operation can be conducted within 2 weeks of injury

Exclusion Criteria:

• Fracture-dislocations

• Head-splitting fractures

• Previous shoulder surgery on injured side

• Chronic shoulder pain

• Abuse problems

• Patients unable to understand instructions in Danish

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Non-surgical management
Non-surgical management (physiotherapy and self-training)
• Osteosynthesis
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
• Hemiarthroplasty
Primary modular hemiarthroplasty followed by physiotherapy and self-training

Locations

Country	Name	City	State
Denmark	Herlev University Hospital, Department Orthopaedic Surgery	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Herlev Hospital	Aalborg Universitetshospital, Koege Sygehus, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Disability Scale		3 years	No
Secondary	Oxford Shoulder Score, Short Form-36		3 years	No