MedTrace Logo

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

NCT00835562 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2012-06-07

No results posted yet for this study

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.

Conditions

  • Proximal Humeral Fractures

Interventions

PROCEDURE

Non-surgical management

Non-surgical management (physiotherapy and self-training)

PROCEDURE

Osteosynthesis

Osteosynthesis with angle-stable plate followed by physiotherapy and self-training

PROCEDURE

Hemiarthroplasty

Primary modular hemiarthroplasty followed by physiotherapy and self-training

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-03-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835562 on ClinicalTrials.gov