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

University Hospital, Aker50 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Proximal Humeral Fracture Osteosynthesis or Conservative Treatment

Interventions

Surgical treatment with LCPPROCEDURE

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital

Oslo, Norway

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

Secondary Outcomes

QALY (HRQoL score according to Harri Sintonen 15D and Costs)

Time frame: 12 and 24 months

ASES score (modified self assessment) C) Radiographic score

Time frame: 12 and 24 months

Radiographic score

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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