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

Phase 2

Completed

• Conditions: Proximal Humeral Fracture; Osteosynthesis or Conservative Treatment
• Interventions: Procedure: Surgical treatment with LCP

• Registration Number: NCT00863473
• Lead Sponsor: University Hospital, Aker

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery with LCP T plate	Surgical treatment with LCP	Surgical treatment with interlocking plate

Primary Outcome Measures

Name	Time	Method
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).	12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Radiographic score	12 and 24 months
QALY (HRQoL score according to Harri Sintonen 15D and Costs)	12 and 24 months
ASES score (modified self assessment) C) Radiographic score	12 and 24 months

Trial Locations

Locations (1)

Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital; 🇳🇴 Oslo, Norway