Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

University Hospital, Aker

Status and phase: Completed; Phase 2

Conditions: Proximal Humeral Fracture; Osteosynthesis or Conservative Treatment

Treatments: Procedure: Surgical treatment with LCP

Study type: Interventional

Funder types: Other

Identifiers

NCT00863473

AkerU_s422

Details and patient eligibility

About

1. Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year?
2. Do surgical treatment gain more QALY than conservative treatment after one year?

Enrollment: 50 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital

Exclusion criteria

• aged less than 60 year
• patients of non-Scandinavian ethnicity
• previous history of injury or illness of the injured or contralateral shoulder
• injury of other part of the humerus or the contralateral upper extremity,
• alcohol- or drug abuse
• dementia or neurological diseases
• severe cardiovascular disease that would contraindicate surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Conservative /Physiotherapy

No Intervention group

Description:

Active training protocol with instructed physiotherapy and self excercises

Surgery with LCP T plate

Active Comparator group

Description:

Surgical treatment with interlocking plate

Treatment:

Procedure: Surgical treatment with LCP