Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial

University Hospital, Aker1 site in 1 country50 target enrollmentMay 2003

ConditionsProximal Humeral Fracture Osteosynthesis or Conservative Treatment

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Proximal Humeral Fracture
Sponsor: University Hospital, Aker
Enrollment: 50
Locations: 1
Primary Endpoint: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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?
Do surgical treatment gain more QALY than conservative treatment after one year?

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

May 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Aker

Responsible Party

Principal Investigator

Tore Fjalestad

MD PhD Consultant

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).

Time Frame: 12 and 24 months