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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00835562
Enrollment
162
Registered
2009-02-03
Start date
2009-04-30
Completion date
Unknown
Last updated
2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Humeral Fractures

Keywords

Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus

Brief 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.

Interventions

Non-surgical management (physiotherapy and self-training)

PROCEDUREOsteosynthesis

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

PROCEDUREHemiarthroplasty

Primary modular hemiarthroplasty followed by physiotherapy and self-training

Sponsors

Aalborg University Hospital
CollaboratorOTHER
Zealand University Hospital
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Constant Disability Scale3 years

Secondary

MeasureTime frame
Oxford Shoulder Score, Short Form-363 years

Countries

Denmark

Contacts

Primary ContactStig Brorson, MD, PhD
sbrorson@hotmail.com
Backup ContactAsbjørn Hrobjartsson, MD, PhD
ah@cochrane.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026