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